Hyman Phelps and McNamara
Search Firm Publications
  California Enacts Law to Increase Drug Pricing Transparency,  October 13, 2017
  A Spark Points the Way Forward on Gene Therapy,  October 12, 2017
  FDA’s Getting a Complex,  October 8, 2017
  Commissioner Gottlieb’s Statement: “We Want You”..Seeking Able-Bodied Compounders to Register as Outsourcing Facilities Pursuant to FDCA Section 503B,  October 4, 2017
  Drug Manufacturers Shed No Tears Over Ruling that State Law Claims Based on Eye Drop Dispensers are Preempted,  October 4, 2017
  FDA Finalizes Product Classification Guidance,  October 3, 2017
  Pharmaceutical Manufacturing in Puerto Rico after Maria– Where does it go from here?,  September 28, 2017
  FDA’s Approach to Analytical Similarity for Proposed Biosimilars,  September 27, 2017
  Regenerative Medicine Advanced Therapy: FDA’s Newest Expedited Program Evolves to Keep Pace with Recommendations,  September 27, 2017
  Fifth Circuit Upholds Summary Judgment for Solvay Pharmaceuticals in Off-Label and Anti-Kickback FCA Case,  September 20, 2017
  No State Law Allowed: U.S. Weighs in on BPCIA Federal Preemption,  September 14, 2017
  ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II: A Follow-Up,  September 13,2017
  Accelerating Accelerated Approval & Other Drug Development Signals from FDA’s Approval of 1st Therapy for Chagas,  September 13, 2017
  REMS Program Violations Result in Disgorgement and False Claims Act Liability,  September 6, 2017
  DC Circuit Rules for FDA in 3-Year Exclusivity Dispute; Hashes Out ABILIFY’s “Zone of Exclusivity” vis-à-vis ARISTADA,  August 31, 2017
  Trailblazer Amarin Takes on a New Fight with ITC Complaint Against Synthetic Omega-3 Oil Manufacturers and Dietary Supplement Distributors,  August 30, 2017
  A Change in Direction on Stem Cell Policy? It’s About Time,  August 28, 2017
  FDA Goes Farther Down the 3-Year Exclusivity Rabbit Hole With XTAMPZA ER-ROXYBOND Exclusivity Decision,  August 15, 2017
  Discovery in the BPCIA Era: Federal Circuit Rules in Amgen v. Hospira EPOGEN Biosimilar Dispute,  August 13, 2017
  FDA Issues Draft Guidance on Voluntary Child-Resistant Packaging Statements in Drug Product Labeling,  August 11, 2017
  United Therapeutics Sues FDA After Agency Denies Orphan Drug Exclusivity for ORENITRAM,  August 9, 2017
  Word to the Wise (Drug Manufacturer): Don't Use Your Manufacturing Equipment to Produce Toxic, Non-Pharmaceutical Products,  August 8, 2017
  Celgene Pays $280m in False Claims Act Case in Which U.S. Did Not Intervene,  August 1, 2017
  FDA Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations: A Holdover until Rulemaking,  July 31, 2017
  Fitting New Scientific Advances Into an Old Regulatory Paradigm (Part 2): Gene Therapy and Orphan Drug “Sameness”,  July 26, 2017
  Fitting New Scientific Advances Into an Old Regulatory Paradigm: Fusion Proteins and Orphan Drug “Sameness”,  July 25, 2017
  United States v. Medistat RX LLC Consent Decree: FDA’s Latest Enforcement Effort Related to Compounders and Title I of the Compounding Quality Act,  July 24, 2017
  All Backed Up: FDA Reverses Course and Denies NCE Exclusivity for PREPOPIK,  July 23, 2017
  GAO Provides Report Card on FDA’s Expanded Access Program,  July 19, 2017
  FDA’s Hatch-Waxman Public Meeting and Progression of the Agency's Drug Competition Action Plan,  July 19, 2017
  FDA Determines that Deuterated Compounds are NCEs and Different Orphan Drugs Versus Non-deuterated Versions,  July 16, 2017
  cGMP Problems Shrink the DepoCyt Chemotherapy Market,  July 13, 2017
  Generic Drug Trade Association Sues to Enjoin Maryland Price Gouging Law,  July 10, 2017
  Never Stop Never Stopping: More Questions About the BPCIA Continue to Arise,  July 5, 2017
  Should the Best Pharmaceuticals for Children Act be Amended to Accommodate 505(b)(2) NDA Labeling Carve-outs? “YES”, According to a Bill in the Senate,  July 4, 2017
  Any Drug Manufacturer (Repackager, Dispenser, Distributor) Affected by the Serialization Deadline in the Drug Supply Chain Security Act Should Read ,  July 2, 2017
  ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II,  June 28, 2017
  A Few More Steps in FDA’s Drug Competition Action Plan,  June 27, 2017
  GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees,  June 27, 2017
  A Meeting to Discuss FDA’s Continuing Conundrum: Innovation vs. Access,  June 21, 2017
  FDA, Ahead of GDUFA II Enactment, Starts the Ball Rolling with Pre-Submission Facility Correspondence Guidance,  June 20, 2017
  Nevada Transparency Bill Targets Diabetes Drugs and Payments to Health Care Providers,  June 20, 2017
  U.S. Supreme Court Rules in Amgen v. Sandoz; Gives a Potential Boost to the Biosimilars Industry,  June 12, 2017
  User Fee Reauthorization Moves One Step Closer to Reality with House Committee Passage,  June 8, 2017
  Adieu, “Orange Book FR Safety or Effectiveness Determinations List”; Hello, “Orange Book Patent Listing Dispute List”,  June 6, 2017
  Amgen SENSIPAR Pediatric Exclusivity Dispute is Put on Ice While FDA Dispute Resolution Process Proceeds,  June 5, 2017
  First Generic Drug Price Gouging Prohibition to Become Law in Maryland,  June 1, 2017
  Letter Signed by 65 Members of Congress Urges FDA to Reconsider “Office Stock” Restrictions for Section 503A Compounders,  May 31, 2017
  Amgen Sues FDA After Agency Denies Pediatric Exclusivity for SENSIPAR,  May 30, 2017
  If Everyone’s Unhappy, Maybe You’re Doing Something Right… Comment Period on FDA’s Biosimilar Interchangeability Guidance Closes,  May 29, 2017
  For the Love of Money: The Trump Administration’s Fiscal Year 2018 FDA Budget Plan,  May 23, 2017
  Schrader Amendment to House UFA Package Creates New “Competitive Generic Therapy” Pathway and 180-Day Exclusivity,  May 19, 2017
  FDA, Under New Leadership, Seeks More Comments on Rules Affecting Off-Label Communications,  May 18, 2017
  Examining the “Drug Innovation Paradox”: Should the Length of Exclusivity Reflect the Time it Takes to Develop a Drug?,  May 10, 2017
  FDA User Fee Package Includes “Technical Corrections” to Address Orphan Drug Clinical Superiority,  May 9, 2017
  FDA’s Ruling on Generic ZITHROMAX 180-Day Exclusivity: A Little Something for Everyone!,  May 8, 2017
  Texas Department of Criminal Justice Challenges FDA Thiopental Sodium Import Prohibition,  May 1, 2017
  Apotex Petitons FDA on Biosimilar NEULASTA; Wants Comparative Clinical Efficacy Studies in at Least One Patient Population,  April 26, 2017
  FDA Licences Renflexis; Some Firsts for this Remicade Biosimilar,  April 24, 2017
  Congress Releases a (Near) Clean Draft User Fee Bill; Includes Restructured Assessment of Fees & Very Limited Policy Riders,  April 20, 2017
  Another False Claims Act Case Dismissed in the Post-Escobar Landscape,  April 12, 2017
  Congress Seeks a Statutory Fix to Stymied Off-Label Discussions,  April 10, 2017
  Griffith Bill Proposes Legislative Fix to “Route-of-Abuse” Exclusivity Block,  April 9, 2017
  Is a Challenge to FDA’s “Route-of-Abuse” 3-Year Exclusivity Approach to Abuse-Deterrent Drug Products on the Horizon?,  April 6, 2017
  The Improving Access to Affordable Prescription Drugs Act: A Different Tack on Exclusivity,  April 5, 2017
  Jury Rules on Charges against Owner and Head Pharmacist of NECC,  April 4, 2017
  The Hidden Orange Book: Breaking Up Is Hard to Do (But Sometimes It’s for the Best),  March 29, 2017
  Is a Hatch-Waxman 30-Month Stay Terminated if the Dismissal of a Patent Infringement Action is Later Vacated? FDA Says “No”,  March 28, 2017
  Down the Tubes: FDA Settles PREPOPIK NCE Exclusivity Dispute; ANDA Submissions in Unsettled State,  March 27, 2017
  Delay Is a Good Thing,  March 22, 2017
  HP&M’s Frank Sasinowski and Kurt Karst Highlight Regulatory Innovations in Neurotherapeutics at the ASENT 19th Annual Meeting,  March 20, 2017
  Should the Best Pharmaceuticals for Children Act be Amended to Accommodate 505(b)(2) NDA Labeling Carve-outs?,  March 16, 2017
  GAO Issues Report on Qualified Infectious Disease Products,  March 13, 2017
  Orphan Drugs: The Current Firestorm, a Real Evergreening Issue, and a Possible Solution,  March 12, 2017
  A New Rulemaking Is Needed for the Intended Use Regulation,  March 9, 2017
  How To Get Rid of The “Totality of the Evidence” Amendment to The Intended Use Regulation,  March 7, 2017
  Drug Debarment Actions: Beware,  February 26, 2017
  FDA Defines the Scope of 3-Year Exclusivity for MORPHABOND After Wrestling With Different Approaches,  February 21, 2017
  Do President Trump’s Regulatory Freeze-Out and “1-in-2-Out” Orders Affect the Regulation of Compounding?,  February 20, 2017
  The Problem of the “Intended Use” Regulations Continues to Fester,  February 19, 2017
  Amgen and the BPCIA Patent Dance – Redux,  February 19, 2017
  The Final Common Rule: Much Either Retained or Removed, But Not Much New Added,  February 16, 2017
  Abuse-Deterrence and 3-Year Exclusivity: FDA Decisions Further Elucidate Scope and a “Route of Abuse” Approach to Exclusivity,  February 9, 2017
  The FTC Takes Action for Alleged Anticompetitive Citizen Petitioning Activities Surrounding Generic VANCOCIN,  February 7, 2017
  FDA’s 180-Day Exclusivity Q&A Guidance: Two Items of Note,  February 5,2017
  The Lower Drug Costs Through Competition Act: Prioritized Review for Some ANDAs . . . and a Priority Review Voucher,  February 1, 2017
  Some Noteworthy Changes to the 2017 Orange Book Preface & Patent and Exclusivity Information Addendum,  January31, 2017
  FDA Sued Over 180-Day Exclusivity Determination for Generic NAMENDA XR; It’s All About the “Causal Connection”,  January 30, 2017
  Meet the Regenerative Advanced Therapy Designation,  January 29, 2017
  505(b)(2) NDA and ANDA Amendments: Don’t Forget to Meet the New Verification Requirement,  January 26, 2017
  Orphan Drug Approvals and Designations Dipped in 2016, But Orphan Drug Designation Requests Skyrocketed,  January 25, 2017
  Bigger, Better, Faster, Stronger: The New Orange Book Makes Its Debut,  January 24, 2017
  Winter Freeze Descends on Nation’s Capital,  January 23, 2017
  OPDP Doubles Enforcement Letters, But is Carefully Picking Its Battles,  January 19, 2017
  FDA Issues Final Guidance Addressing Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities,  January 18, 2017
  FDA’s Publishes (Yet Another) Interim Policy on Compounding with Bulk Substances for Both Section 503A and Section 503B Compounders,  January 17, 2017
  At long last, FDA Issues Guidance on Biosimilar Interchangeability,  January 17, 2017
  Drug Compounding: FDA Issues Final Guidance on Section 503A’s Individually Identified Prescription Requirement, With At Least Three Noteworthy Change,  January 11, 2017
  Need Some Holiday Reading? Recent FDA Scholarship Worth a Spin,  December 28, 2016
  When Does the Expiration of Pediatric Exclusivity Allow ANDA (or 505(b)(2) NDA) Approval? The Case of Generic BENICAR,  December 27, 2016
  Now You See It, Now You Don’t: Vanishing Drug Approval Information and Other FDA Actions Making Drug Approvals Opaque,  December 22, 2016
  Cures Act Changes Regarding the Regulation of Combination Products (Section 3038); Importing Hatch-Waxman Into Medical Device Approval/Clearance,  December 19, 2016
  FDA Finalizes DSCSA Guidance on “Identification of Suspect Product and Notification” with A Twist,  December 19, 2016
  Not Dead Yet – OPDP Issues Two Untitled Letters Late in the Year (Our 3,000th Post!),  December 18, 2016
  Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two),  December 15, 2016
  The President Signs 21st Century Cures into Law; Highlights of Drug and Biologic Related Provisions (Part One),  December 13, 2016
  Solicitor General Urges SCOTUS to Take Up Sandoz and Amgen Petitions on the BPCIA’s Notice and Patent Dance Provisions,  December 8,2016
  Will Any of FDA’s Recent Rules Wind Up On the Congressional Chopping Block?,  December 7, 2016
  FDA’s Draft Quality Metrics Guidance, Version 2.0,  December 5, 2016
  Breaking Zen: FDA Denies Vanda’s Petition on FANAPT 3-Year Exclusivity; Approves Generic,  December 4, 2016
  Noteworthy Takeaways From FDA’s 180-Day Exclusivity Forfeiture Decision on Generic EDLUAR,  November 29, 2016
  A Practical Roadmap for Transitioning State Licenses for Sales of Prescription Drugs and Devices in Corporate Transactions  November, 2016
  States in the Mix: GAO Releases Report to Congressional Committees on Drug Compounding,  November 24, 2016
  HHS OIG’s Latest Work Plan: What to Look Out for in FY2017,  November 22, 2016
  A New Orange Book First: FDA Unilaterally Changes a Patent Use Code,  November 20, 2016
  FDA Appeals PREPOPIK NCE Exclusivity Decision to the D.C. Circuit; Similarly Situated Parties Petition FDA,  November 16, 2016
  How FDA Announces Drug Approval Decisions: A Broken FDA “System” That Must Be Fixed,  November 6, 2016
  Keeping Up with ..... FDA’s Drug Compounding Lists: Todays PCAC Meeting,  November 2, 2016
  The Update Continues: FDA’s List of Drugs that May Not Be Compounded Under 503A and 503B,  October 27, 2016
  As the Patient-Focused Drug Development “Pilot” under PDUFA V Concludes, Is FDA Passing the Baton to Patient Organizations?,  October 18
  FDAAA Asked & NIH Answered: The Final Rule on Clinical Trials Registration and Results Reporting,  October 11, 2016
  Court Rejects Prosecution of Pharmacists Due to Lack of Fair Notice in FDC Act,  October 10, 2016
  FDA Updates List of Drugs that May Not Be Compounded Under 503A and 503B: Preamble Reminds Industry when Listed Drugs Can Still Be Compounded,  October 9, 2016j
  FDA Issues Final Hatch-Waxman Regulations to Implement Some of the Provisions of the 2003 Medicare Modernization Act,  October 6, 2016
  Pediatric Priority Review Vouchers Saved in the Eleventh Hour,  October 4, 2016
  Ninth Circuit Confounds Practice of Medicine and Off-Label Use Issues,  September 28, 2016
  Senate Votes to Extend Pediatric Voucher Program and Expand Eligibility,  September 26, 2016
  FDA Licenses First HUMIRA Biosimilar; Denies AbbVie Petition on Fifth Amendment Takings,  September 26, 2016
  The Pediatric Voucher Program and Its Impending Renewal Deadline,  September 22, 2016
  FDA Electronic Registration for Human Drugs, Animal Drugs, and BLAs,  September 19, 2016d
  On Second Thought: DC District Court Does a 180 on PREPOPIK NCE Exclusivity; Remands to FDA,  September 13, 2016
  Rehearing Sought in Colchicine 505(b)(2) Listed Drug/Patent Certification Dispute,  September 6, 2016
  Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay  September 2016
  FDA To Hold Two-Day Hearing on Off-Label Communications,  September 1, 2016
  Did You Catch That “New” Drug Product Addition to the Orange Book?,  August 25, 2016
  FDA’s Eighth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers, But the Same Punchline,  August 23, 2016
  FDA Prevails in PRADAXA Patent Term Extension Regulatory Review Period Challenge,  August 22, 2016
  DC Circuit Affirms MITIGARE 505(b)(2) NDA Approval, and Sidesteps COLCRYS Patent Certification Issue,  August 11, 2016
  NIH Intends to Open New Manufacturing Facility by End of October,  August 8, 2016
  Insanitary Conditions 101: FDA Issues Draft Guidance for Compounding Facilities Based on Prior FDA Inspections: Comments due October 3, 2016,  August 7, 2016
  FDA Publishes Fiscal Year 2017 User Fee Rates: Across-the-Board Decreases in PDUFA/BsUFA Rates; Facilities Get Hit With GDUFA Fee Increases,  August 1, 2016
  FDA Prevails in Otsuka Challenge to Scope of ABILIFY 3-Year Exclusivity, Leaving Intact ARISTADA 505(b)(2) NDA Approval,  July 31, 2016
  The Third Time’s the Charm for RAVICTI and Orphan Drug Designation: Another “Greater Safety” Clinical Superiority Precedent,  July 25, 2016
  FDA’s Mutual Reliance Initiative – Saving FDA Some Money at the Expense of Inspectional Quality?,  July 18, 2016
  CMS Issues Release to Manufacturers Regarding Value-Based Purchasing Arrangements,  July 18, 2016
  FDA Publishes Draft Guidance on What is “Essentially” a Copy of a Commercially Available Drug Under FDCA Sections 503A & 503B: Outsourcing Facilities,  July 15, 2016
  FDA Publishes Draft Guidance on What is “Essentially” a Copy of a Commercially Available Drug Under FDCA Sections 503A & 503B: Section503A Compounders,  July 14, 2016
  Chemistry Amendment Saves Sun From Forfeiting 180-Day Exclusivity Eligibility for Generic GLEEVEC,  July 13, 2016
  A New “Greater Safety” Orphan Drug Clinical Superiority Precedent: PURIXAN????,  July 5, 2016
  Lannett Sues FDA Over Temozolomide Capsules ANDA Approval Rescission,  June 28, 2016
  The PRICED Act Takes a Stab at Reducing Biological Product Reference Product Exclusivity From 12 Years to 7 Years,  June 23, 2016
  A New and Improved (Updated) List of Pending DESI Program Proceedings,  June 21,2016
  FDA Publishes Final “Interim Policy” for Both Sections 503A and 503B Compounding from Bulk Substances: Section 503B Bulks,  June 20, 2016
  The CREATES Act Would Create a Cause of Action to Obtain Restricted Product Sample and to Facilitate Shared REMS,  June 17, 2016
  Just When FDA Thought It Was Out, They Pull It Back In: AstraZeneca Raises 505A(o) and Orphan Drug Exclusivity Carve-Outs in CRESTOR Petition,  June 8, 2016
  FDA, Sandoz Prevail at D.C. Circuit on Generic FUSILEV Approval,  June 6, 2016
  Vermont Responds to Drug Price Increases With Transparency Law,  June 6, 2016
  First the Courts, Now Congress… House Committee Throws its Weight Behind Evolving Legal Landscape of Off-Label Promotion,  June 1, 2016
  It’s Finally Here! FDA’s VASCEPA Exclusivity Determination on Remand: NCE Exclusivity Granted!,  May 31, 2016
  FDA Rejects “Extraordinary” Position in Battle Over BUTRANS Patent Term Extension,  May 23, 2016
  RLD Designation Citizen Petitions: One Item on Our GDUFA II Wish List,  May 18, 2016
  Congress' Dubious Delegation of Legislative Authority to USP Standards Results in Instructions-But Not Dismissal-Related to NECC Criminal Indictment,  May 12, 2016
  FDA Revises Guidance on Special Protocol Assessments, Attempts to Reduce Uncertainty,  May 9, 2016
  HP&M Seeks Alternative Statutory Reading of BPCI Act “Deemed to be a License” Provision,  May 9, 2016
  Speculating About the Prospects of Exclusivity A Potentially Risky Game,  May 5, 2016
  The COMBAT Act Would Add New Brand and Generic Exclusivity-Stacking Incentives for Abuse-Deterrent Opioid Development,  May 2, 2016
  NIH Again Closes Drug Product Manufacturing Facilities and Halts Clinical Studies,  May 1, 2016
  Tested Mettle: Vifor Fresenius Petitions FDA to Make a Decision on NCE Exclusivity for Iron-based Phosphate Binder VELPHORO,  April 27, 2016
  Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future?,  April 26, 2016
  FDA Issues Draft Guidance on Hospital and Health System Compounding: FDA Will Permit Compounding in Advance of Prescription for Hospital Pharmacies,  April 22, 2016
  FDA Addresses “Facility Definition” For Outsourcing Facilities: Manufacturers Can Live With Outsourcing Facilities But Section 503A Compounders Cannot,  April 21, 2016
  What the Doctor Ordered? What the Pharmacist Understood? FDA Issues Compounding Draft Guidance Addressing Compounding for Office Use under FDC Act § 5,  April 21, 2016
  The FTC’s “Pay-for-Delay” Lawsuit Against Endo: Is There a Hole in the Commission’s Generic LIDODERM 180-Day Exclusivity Analysis?,  April 19, 2016
  FDA Licenses a Second Biosimilar – The Parameters of Approval Come Into Better Focus,  April 6, 2016
  FDA’s Biosimilar Labeling Guidance,  April 1, 2016
  Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products,  March 31, 2016
  Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products  March 31 2016
  Compounding the Dilemma over the Permissibility of Office Use Compounding: Congressman Requests Answers to Questions from HHS Secretary Burwell,  March 29, 2016
  Amgen Asks the Supreme Court to Reject Challenge to Ruling that Notice of Commercial Marketing is Mandatory, But Asks for Review of Patent Dance Rulin,  March 28, 2016
  Orphan Drug Clinical Superiority: An Overview of Precedents Shows that MC-to-PC Clinical Superiority is Not so Unusual,  March 27, 2016
  FDA Proposes a Tier-Based Approach to Evaluate “Bioequivalence” of Abuse Deterrence of Generic SODF Opioids,  March 24, 2016
  FDA Updates Breakthrough Therapy Program: Meet the Preliminary Breakthrough Therapy Designation Request,  March 22, 2016
  CDC Guidelines Prescribe Controls on Opioid Therapy,  March 17, 2016
  Not a Blowout: DC District Court Upholds FDAs Pre 2014 Interpretation on NCE Exclusivity for Combos But Wants Additional Briefing on Retroactivity,  March 16, 2016
  FDA’s BPCIA Deemed to be a License Guidance Provides Practical Help with Development, But Limits Exclusivity,  March 14, 2016
  If I Keep Asking You to Dance, Perhaps You’ll Say Yes? Amgen Files a Third Patent Dance Lawsuit Against Sandoz,  March 10, 2016
  Amarin Announces a Proposed Settlement of its First Amendment Lawsuit Against FDA: Coming Full Circle in a New Era of the Regulation of Off-label Prom,  March 8, 2016
  GAO Issues Report on Pediatric Voucher Program, Findings Inconclusive,  March 3, 2016
  Congress Puts Pressure on FDA and Proposes Incentives to Ramp Up Generic Drug Reviews,  March 3, 2016
  Just the Facts, Maam: OGD Director Uhl Provides the Lowdown on GDUFA Implementation,  February 25, 2016
  The Perennial Perils of Aseptic Manufacturing,  February 22, 2016
  Sandoz Petitions High Court to Review the Federal Circuit’s Decision on the BPCIA’s 180 Day Notice of Commercial Marketing Provision,  February 17, 2016
  GAO Report on the Safety of Drugs Approved Using Expedited Programs Finds Shortcomings in FDA’s Postmarket Oversight Reviews Use of Expedited Program,  February 16, 2016
  An Oldie But a Goodie: Revisiting a Not-Quite Yet Vestigial Remnant of a Pre-MMA Era,  February 15, 2016
  Our First of Many Drug cGMP Compliance Updates: CDER’s First cGMP Warning Letter of 2016, to Ipca Laboratories Ltd., cites Data Integrity Violations,  February 14, 2016
  NDA Approval Date Resets: More Than a One-off,  February 10, 2016
  Orphan Drug Approvals Dipped in 2015, While Designations and Designation Requests Continue Upward Trend,  February 9, 2016
  Eisai Says That the Recently Enacted IRTNMTA Should Result in a Longer PTE for FYCOMPA Patent,  February 8, 2016
  FDA’s Orange Book Preface Gets a Facelift: What’s New?,  February 3, 2016
  Trailblazer Amarin Continues to Blaze New Trails: ANDA Paragraph IV Litigation Dismissed,  January 27, 2016
  FTC Releases Latest Staff Report on Drug Patent Settlement Agreements; Post-Actavis Trends Seem to Be Forming,  January 19, 2016
  2016/01/briefing-in-appeal-over-colchicine-505b2-approval-wraps-up-oral-argument-and-a-decision-are-patientl.html,  January 13, 2016
  Briefing in Appeal Over Colchicine 505(b)(2) Approval Wraps Up; Oral Argument and a Decision are Patiently Awaited,  January 11, 2016
  FDA Issues Proposal on Prescription and OTC Fixed-Combination and Co-Packaged Products,  December 30, 2015
  New Life for the Pediatric Priority Review Voucher Program,  December 29, 2015
  Any Given Patient for Any Given Indication: AbbVie Petitions FDA on Interchangeable Biosimilars,  December 28, 2015
  Legislators Want GAO Studies on Non-Biologic Complex Drugs & FDA Inspections, and Want a Raft of Documents as Questions are Raised About ANDA Review E,  December 22, 2015
  “C” Will Always Follow “P”, Except When the BPCIA is the “BCPIA”, Says District Court in NEULASTA Decision,  December 14, 2015
  Nearing its Sunset, Pediatric Voucher Program Gains Momentum,  December 13, 2015
  The Ever-Expanding Biosimilar Labeling Debate – Institutional Investors Offer their Opinion and Request FDA to Hold a Hearing,  December 10, 2015
  HP&M Asks FDA Not to Narrowly Constrict the Formal Dispute Resolution Process,  December 8, 2015
  In a Rare Move, FDA Initiates Procedures to Suspend Approval of an ANDA,  December 4, 2015
  Under Control: Some Controlled Substances May Have a Later Exclusivity Start Date With the Enactment of a New Law,  November 30, 2015
  Sex, Drugs, and Rock & Roll (FDA Style): FDA’s Unapproved Drug Machine Continues to Dole Out Enforcement and Legal Decisions,  November 18, 2015
  There’s an App for That Too! FDA Gives a Post-Halloween Treat and Releases the Orange Book Express App,  November 9, 2015
  The Lost MAPP is Found! FDA Releases MAPP on NDA Classification Codes,  November 4, 2015
  FDA to Hold a Public Hearing for a Quartet of Draft HCT/P Guidances: A Scorecard,  November 2, 2015
  Using Bad Names: FTC Says FDA’s Naming Proposal for Biologics will Impede Competition from Biosimilars,  October 29, 2015
  FDA Publishes Interim Guidance on Compounding Using Bulk Drug Substances and Once Again Establishes a Time Period for Comments and Nominations,  October 28, 2015
  Cross-Motions for Summary Judgment Filed in PRADAXA Patent Term Extension Dispute,  October 27, 2015
  Congress Continues Spree of Proposing Alternative Incentives for Product Development: the “CBRN Countermeasure PRV” (Part 1),  October 22, 2015
  You Win Some, You Lose Some: Federal Circuit Denies En Banc Review in BPCIA Dispute & Otsuka Files Suit Over 3-Year Exclusivity,  October 19, 2015
  A Long Overdue Revision to the Intended Use Regulation,  October 18, 2015
  FDA Rules on the Scope of ABILIFY 3-Year Exclusivity and Approves ARISTADA With NCE Exclusivity,  October 7, 2015
  CTTI Releases Recommendations and Tools to Maximize Engagement between Research Sponsors and Patient Groups,  October 7, 2015
  The NPRM for the Common Rule: 88 Questions to Answer in 90 Days,  October 4, 2015
  No False Starts: FDA Prevails in Eisai Challenge Over NCE Exclusivity Start Dates for BELVIQ and FYCOMPA,  September 30, 2015
  FDA’s Seventh Annual Report to Congress on 505(q) Citizen Petitions: A Lot of the Same Old Same Old,  September 29, 2015
  How Effective is a “Depomed Threat” at Resolving an Orphan Drug Clinical Superiority Dispute?,  September 27, 2015
  Amgen Wants Patent Dance Redo and a Halt to Hospira’s EPOGEN Biosimilar,  September 24, 2015
  The Promoting Life-Saving New Therapies for Neonates Act of 2015: A New Twist on Transferable Vouchers,  September 20, 2015
  Latest FDLI Update Magazine Features Analysis of Amarin Case Written by HP&M Attorneys,  September 17, 2015
  FDA Gives a “Nudge Nudge Wink Wink” in Denial of NORD Petition on Special Treatment of Orphan Drugs,  September 15, 2015
  Lather, Rinse, Repeat: Senators Take Another Stab at Passing the Preserve Access to Affordable Generics Act,  September 14, 2015
  Multiple Parties Chime in as the Federal Circuit Gears Up for a Rehearing in the ZARXIO Biosimilar Patent Dance/180-Day Notice Appeal,  September 9, 2015
  In Appeal Over Colchicine 505(b)(2) Approval, Plaintiffs-Appellants and PhRMA Allege Lower Court Decision Upsets Hatch-Waxman Scheme,  September 9, 2015
  Waking From a Drug Coma: How to Bring a Drug Out of Discontinued Status – It’s As Easy As 1, 2, 3 . . . 4, and 5,  September 7, 2015
  Latest Developments in the Amarin Litigation – Does Settlement Loom? And What Would it Mean?,  August 31, 2015
  Priority Review Voucher Updates: Valuation, Eligibility, Reauthorization,  August 30, 2015
  FDA Semi-Decides the Biosimilar Naming Issue; Issues Draft Guidance and a Proposed Rule,  August 28, 2015
  FDA Releases Primer on Rare Disease Drug Development, Discusses Utility of Natural History Studies,  August 26, 2015
  FDA Sets Expectations for Improving Therapeutic Consistency in the Development of Botanical Drugs,  August 25, 2015
  AbbVie Presses FDA to Make Biosimilar Labeling Show Differences from Reference Sponsor Labeling,  August 23, 2015
  Clearing the Air on Pre-GDUFA Year 3 ANDAs; OGD Issues Revised (and Much Improved) Communications MAPP,  August 18, 2015
  You’re Better Than My Last Dance Partner But Still Not Perfect: Amgen Alleges that an Otherwise Complete Patent Dance Was Ruined by Pre-Approval Notic,  August 17, 2015
  FDA Prevails in Challenge Over Methylphenidate ANDA Rating Downgrade, But the Decision is Appealed; Meanwhile, the Agency Flip-Flops on Dexmethylpheni,  August 12, 2015
  A Victory for Amarin Further Erodes FDA Regulation of Off-label Promotion,  August 10, 2015
  A Look At FDA’s Rationale for Granting – and the Scope of – Exclusivity for Abuse-Deterrent OXYCONTIN,  August 10, 2015
  FDA Publishes Fiscal Year 2016 User Fee Rates; Only a Modest Increase in PDUFA/BsUFA Rates, But Significant Hikes for Some GDUFA Fees,  August 2, 2015
  The Veloxis Case: Uncut, Unrated, and Unsealed!,  July 29, 2015
  Who’s on First? FDA Raises the Specter of 180-Day Exclusivity Eligibility/Forfeiture for Generic RESTASIS and Asks If There’s a Phantom “First Applica,  July 28, 2015
  FDASIA 706 and 711 Have Come Home to Roost,  July 28, 2015
  Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations Bills,  July 24, 2015
  FDA Releases White Paper on the Speed of Drug Discovery and Development,  July 22, 2015
  BPCIA Federal Circuit Follies, or Can We All Agree to Disagree? A Divided Federal Circuit Finds the Patent Dance Voluntary, But Rules that Notice of C,  July 21, 2015
  A Walk Among the SBAs: Waxing Poetic on a Bygone Era, the Development of the Exclusivity Summary, and the Need for Change,  July 16, 2015
  Room for Flexibility in FDA's "Gold Standard" of Drug Approval  July 16, 2015
  Pediatric Priority Review Vouchers: A Subtle Upgrade to Renewal Plans,  July 15, 2015
  The Right to Try Act of 2015 –A Serious Challenge to FDA Control of Expanded Access?,  July 13, 2015
  FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products,  July 10, 2015
  Pediatric Exclusivity: Amazingly Powerful, Essentially Ironclad . . . and Often Overlooked,  July 7, 2015
  BIO & NORD Report Explores a World With and Without the Orphan Drug Tax Credit,  July 6, 2015
  What’s Next for Patient-Focused Drug Development? FDA Announces Final PFDD Meetings, and BIO Recommends Broader Use of the Benefit-Risk Framework,  July 1, 2015
  With One Day Remaining Before July 1 Compliance Date, FDA Exercises Enforcement Discretion of DSCSA’s Product-Tracing Requirements for Dispensers,  June 30, 2015
  Pharmacists Associations Petition FDA to Utilize Enforcement Discretion as July 1 Deadline for Product-Tracing Compliance Nears,  June 25, 2015
  In Case You Missed It . . . . We Did! Prometheus Takes Action Against FDA Over Generic LOTRONEX Approval and REMS Waiver, and Then Promptly Drops Case,  June 24, 2015
  Chipping Away at FOIA Exemptions: The Next Step in FDA’s Campaign to Release Complete Response Letters for Unapproved Drugs,  June 22, 2015
  District Court Rules for FDA in Battle Over the Scope of 3-Year Exclusivity in the Context of Dueling Tacrolimus NDAs,  June 17, 2015
  Should Non-Patent Exclusivity be Conditioned on Launch Price? One Scholar Puts Forth “A Modest Proposal”,  June 15, 2015
  How Often Are Drugs Withdrawn For Safety or Effectiveness Reasons (and How Many)? Not Too Often in Recent Years, But There is a Tranche of Withdrawals,  June 14, 2015
  FDA’s Draft Guidance Helps Clarify Which Changes to Established Conditions are Reportable CMC Changes; Describes Process for Setting Out Established C,  June 8, 2015
  NCE Exclusivity Challenges are hot! Hot! HOT! Ferring Lets Loose with the Latest Lawsuit Challenging Denial of NCE Exclusivity for Colon Cleansing Dru,  June 8, 2015
  Return of the Scarlet Letter? AbbVie Petitions FDA to Require Biosimilar Labeling to Include Disclaimers and a Description of Data Differences,  June 3, 2015
  All’s Quiet on the Eastern Front on the Eve of Oral Argument in Dispute Over BPCIA Provisions,  June 2, 2015
  All For One and One For All? NOPE! Court Rejects FDA’s “One-to-Many” Complex Mixture NCE Exclusivity Decision on VASCEPA; Remands to FDA,  May 28, 2015
  Bam! Bam! Two Plaintiffs Fall in Two District Court Decisions Concerning Orphan Drug Exclusivity Carve-Outs,  May 28, 2015
  Senator Vitter Proposes to Tweak Statute to Explicitly Permit Office Use Compounding ... As Permitted Under State Law, and to Eliminate “Addressing In,  May 27, 2015
  Another Punt Return Resolving 180-Day Exclusivity; This Time a True Post-MMA Case Made in the Context of Lamotrigine Orally Disintegrating Tablets,  May 18, 2015
  The 21st Century Cures Act Evolves and Moves into Mark-Up,  May 14, 2015
  Breaking Down BIMO,  May 12, 2015
  Biosimilar Guidances Finalized–How to Use Data on Non-US-Licensed Product, How to Extrapolate Data to Get Approval in Other Indications,  May 3, 2015
  It’s Been One of “Those Weeks” in Hatch-Waxman World: Another Two Lawsuits and Two Court Decisions,  April 30, 2015
  You’re Invited . . . To a Dance Party! Will You Dance the Amgen Waltz, or the Sandoz Shuffle?,  April 27, 2015
  CDER Announces Public Compendium of Clinical Outcome Assessments with Hopes of Facilitating Greater Use in Drug Development,  April 20, 2015
  Awesome Baby; We Love This Game! An Update on Pending Hatch-Waxman and BPCIA Litigation,  April 8, 2015
  FDA Revises Formal Meetings Guidance for PDUFA Products,  April 6, 2015
  Federal Circuit Rules that a Statutory Patent Disclaimer is Sufficient to Trigger Hatch-Waxman DJ Jurisdiction; Will It Be Enough to Trigger a Forfeit,  April 5, 2015
  Critical Path Innovation Meetings: A New Opportunity to Discuss Drug Development Issues with FDA,  April 2, 2015
  Bringing Your Pharmaceutical Drug to Market  April 1, 2015
  Somebody’s Thinking Ahead! New Legislation Seeks Some Clarity as the BPCIA’s March 2020 Transition Deadline Appears on the Horizon,  March 30, 2015
  The PATIENT Act’s Proposed Exclusivity-Stacking Two-Year Extension: Is it an Incentive, a Reverse Incentive . . . or Both?,  March 30, 2015
  The Advancing Hope Act of 2015 – A First Shot at Reauthorizing the Rare Pediatric Disease Priority Review Voucher Program,  March 26, 2015
  Denied Again! Another Obstacle to Biosimilar First Launch Falls with FDA Rejection of Amgen’s Certification Petition; Meanwhile, an Appeal is Filed in,  March 26, 2015
  Otsuka Sues FDA Over “Corrected” ABILIFY Approval; Alleges Violation of the Most Fundamental Precept of FDA’s Statutory Drug Approval Authority,  March 25, 2015
  One, Two, Three . . . and They’re Out! FDA Issues Third Rare Pediatric Disease Priority Review Voucher, Triggering One-Year Sunset Clause,  March 23, 2015
  Denied! District Court Rules in NEUPOGEN Biosimilar Litigation; Says that the BPCIA’s “Patent Dance” Procedures are Optional, and Notice Can Come,  March 20, 2015
  Protecting Patent Exclusivity: House Passes Bill to Ensure that Drug Scheduling Does Not Adversely Effect Marketing of NCEs,  March 17, 2015
  The Everlasting Patent: Is it Hiding in Plain Sight in the 21st Century Cures Act?,  March 16, 2015
  FDA Formalizes Procedures for Expediting Review of Certain Applications with Breakthrough Therapy Designation,  March 13, 2015
  A Warning Letter on FDA's Expansive Interpretation of Its Facilities - Inspection Authority  March 13, 2015
  FDA Allows for Electronic Informed Consent, Provides Guidelines for Meeting Regulatory Requirements,  March 11, 2015
  Golden Ticket: United Therapeutics Grabs the Second Rare Pediatric Disease Priority Review Voucher With UNITUXIN Approval,  March 10, 2015
  FDA Announces Establishment of a Public Docket to Receive General Public Comments on Compounding,  March 8, 2015
  FDA’s Anti-Franchising Policy: What Is It and Where Did It Come From?,  March 4, 2015
  FDA SOS Act Makes Reappearance as Concern Over Sequestration Grows,  March 2, 2015
  Drug Diversion Administrative Revocation and Application Hearings for Medical and Pharmacy Practitioners  February 28, 2015
  No Leg to Stand On: Sandoz Takes on Amgen’s Bid for an Injunction in Filgrastim Biosimilar Litigation,  February 27, 2015
  District Court Rules that Maine Drug Importation Law is Unconstitutional and Preempted by the FDC Act,  February 25, 2015
  A New Variation on an Old Theme: FDA Refuses PTE Regulatory Review Period Revision Based on Filing Refusal Decision,  February 24, 2015
  How Orphan Drugs Came to Be Called “Orphan”,  February 22, 2015
  FDA Officially Releases Four Compounding Draft Guidance Documents and Its Draft Memorandum of Understanding; Part Two: FDA Provides Details on the Dra,  February 19, 2015
  Would You Balk at Disclosing Confidential Information to Your Competitors?,  February 18, 2015
  Can the AIA’s New IPR and PGR Post-Grant Proceedings Trigger a Forfeiture of 180-Day Exclusivity Under the Failure-to-Market Provisions?,  February 17, 2015
  Another Holiday Surprise: FDA Releases Four Draft Guidances and a Draft Memorandum of Understanding Related to Drug Compounding,  February 16, 2015
  The 2014 Numbers Are In: FDA’s Orphan Drug Program Shatters Records,  February 15, 2015
  We Need to Move the Freight and Not be Late, Says OGD’s Uhl in GDUFA Update; But for Many in Industry, “Seeing is Believing”,  February 12, 2015
  FINALLY! Multiple Generic Companies Receive FDA Final Approval to Market Generic Versions of Celebrex®,  February 12, 2015
  FDA Draft Guidance on Disclosing Risk Information Discourages Companies From Meeting Current Regulatory Requirements,  February 10, 2015
  The 21st Century Cures Act: Putting Patients First, Literally and … Substantively (And FDA’s New Expanded Access Form),  February 9, 2015
  Is the MIA DOA? Bill to Assess Fees on Top of Settlements Doesn’t Receive Bipartisan Love,  February 5, 2015
  Diary of a Hatch-Waxman Addict – Day 4,079: They’re Here! FDA Finally Proposes Regulations to Implement Some of the Provisions of the 2003 MMA!,  February 5, 2015
  Mining the Bowels of the Orange Book: What Do the Data Reveal?,  February 4, 2015
  IOM and Congress Press On to Expand Clinical Trials Data Sharing, Despite Ongoing NIH Rulemaking,  February 1, 2015
  House Energy & Commerce Committee Releases 21 Century Cures Act Discussion Draft; The Nearly 400-Page Bill Includes More Proposals Than You Can Shake ,  January 28, 2015
  Whoomp! There It Is! The Other Shoe Hits the Floor as FDA Strips Ranbaxy of 180-Day Exclusivity for Generic NEXIUM,  January 26, 2015
  Report Card: FDA Earns a Solid “B” on Timely Responding to Section 505(w) Discontinuation Citizen Petitions,  January 25, 2015
  Changes Proposed to Require Electronic Distribution of Package Inserts,  January 22, 2015
  District Court Tackles Sticky 505(b)(2) Application Issues in an Extensive Memorandum Opinion Involving Colchicine,  January 21, 2015
  FDA’s Office of Generic Drugs Finally Has a Permanent Captain; Kathleen “Cook” Uhl, M.D., Named Permanent Director,  January 15, 2015
  Is Anyone Safe From an FCA Whistleblower Suit?,  January 14, 2015
  District Court Sides with FDA, 505(b)(2) Applicant in Challenge to Colchicine Capsules Approval; An Appeal is in the Works, However,  January 12, 2015
  Novartis’s Biosimilar of Neupogen Clears a Big Hurdle, But Major Issues Remain for it and Other Biosimilars,  January 11, 2015
  U.S. Supreme Court is Asked to Review First-in-the-Nation Safe Drug Disposal Ordinance,  January 6, 2015
  Convergence: Recent Court Actions and Pressure From FDA May Mean the Sun is Finally Setting on the Premature Paragraph IV Notice Strategy,  January 5, 2015
  New Jersey District Court Issues First Written Opinion in REMS Antitrust Litigation Involving ANDA Biostudy Sample Procurement,  January 4, 2015
  FTC Issues First Post-Actavis Staff Report on Drug Patent Settlement Agreements; No Meaningful Conclusions on the Effects of Actavis Decision Can Yet ,  December 28, 2014
  In Keeping With the Spirit of the Season, FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements,  December 26, 2014
  FDA Issues Post-Depomed Policy Statement; Agency Doubles Down on Clinical Superiority Requirement,  December 22, 2014
  Deliverance: FDA is Sued Over the Applicability of 3-Year Exclusivity in the Context of Dueling Tacrolimus NDAs; Agency Gets a Short Reprieve to Make ,  December 18, 2014
  Fourth Circuit Rolls Back District Court Decision on Pre-MMA 180-Day Exclusivity for Generic CELEBREX,  December 17, 2014
  The Proposed NIH Framework for Clinical Trials Registration and Results Reporting: A Closer Look,  December 17, 2014
  Main Street Family Pharmacy Compounder Pleads Guilty to Misdemeanor Violations of the FDCA, and Accepts Probation, a $25,000 Fine and a Permanent Inju,  December 15, 2014
  Expansion of Expanded Access? Federal Right to Try Legislation is Introduced,  December 10, 2014
  Third Circuit Kicks OPANA ER Therapeutic Equivalence Rating Lanham Act Case Back to District Court,  December 8, 2014
  Third Circuit Kicks OPANA ER Therapeutic Equivalence Rating Lanham Act Case Back to District Court,  December 8, 2014
  Exclusivity Creep: OPEN ACT Would Open Up Hatch-Waxman and the BPCIA to Add a 6-Month Extension to Existing Exclusivities,  December 4, 2014
  Exclusivity Creep: OPEN ACT Would Open Up Hatch-Waxman and the BPCIA to Add a 6-Month Extension to Existing Exclusivities,  December 4, 2014
  Something to be Thankful For? FDA Issues Long Awaited DSCSA Guidance,  December 1, 2014
  Without Much Fanfare, FDA Creates System for DSCSA Licensure Reporting,  December 1, 2014
  FDA Clarifies Its Rare Pediatric Disease Priority Review Voucher Program,  November 20, 2014
  First Look: NIH Proposed Rulemaking Would Expand Results Reporting to Unapproved Drugs and Devices, Defers on Expanding Other Types of Results Informa,  November 20, 2014
  Mallinckrodt Sues FDA After Agency Downgrades Therapeutic Equivalence Rating for Generic CONCERTA,  November 19, 2014
  Ranbaxy Sues FDA Over Stripped Tentative Approvals for Generic VALCYTE and NEXIUM and Lost Exclusivity,  November 17, 2014
  FDA Speaks at Annual HDMA Track-and-Trace Conference,  November 13, 2014
  FDA Seeks Comments on Greater Patient Involvement in Medical Product Development,  November 12, 2014
  FDA Withdraws Appeal in the Depomed Case,  November 11, 2014
  One Down, One to Go: FDA Strips Ranbaxy of 180-Day Exclusivity for Generic VALCYTE; Is Generic NEXIUM Next?,  November 6, 2014
  Courtroom Drama Over NEUPOGEN Biosimilar Spills Over to FDA With the First Petition Accompanied by a 505(q) Certification,  November 5, 2014
  FDA Appeals Depomed Orphan Drug Case,  November 4, 2014
  Amgen Sues After Sandoz Abandons the BPCIA Patent Dance Procedures for NEUPOGEN Biosimilar; Alleges Unfair Competition, Patent Infringement, and Theft,  October 29, 2014
  In Draft Guidance on Acute Migraine Treatments, FDA Proposes Novel Efficacy Endpoint,  October 23, 2014
  No Good Precedent Goes Overlooked: FDA is Asked to Reset FUSILEV Approval and Exclusivity Dates Because of Proprietary Name Review,  October 20, 2014
  Invitation Accepted: PhRMA Sues HHS Over Interpretive 340B Orphan Drug Rule,  October 16, 2014
  Statutory Patent Disclaimer Sufficient Enough to Trigger Hatch-Waxman Declaratory Judgment Jurisdiction? 2 District Courts Reach Opposite Conclusions,  October 15, 2014
  AAP Chimes in on Pediatric Exclusivity and Whether a Written Request is a Condition Precedent to FDA Awarding Exclusivity,  October 14, 2014
  FDA Fixes Position on NCE Exclusivity for Certain FDCs; Prospective Effect Only Determination May Mean Some Companies Could be Fixin for a Fight,  October 12, 2014
  FDA Q&A Draft Guidance Clarifies Issue of DSCSA Preemption of State Track and Trace and Licensing Requirements,  October 9, 2014
  Flare Up: Takeda Challenges FDA Approval of 505(b)(2) Application for Colchicine Capsules,  October 8, 2014
  RICO Challenges to Drug Co-Pay Programs Fall Like Dominoes: Another Federal Court Judge Dismisses RICO Claim,  October 6, 2014
  Ninth Circuit Rules Alameda Countys Drug Take-Back and Disposal Ordinance is Not Unconstitutional,  October 1, 2014
  Wildcard Exclusivity Returns: PCAST Recommends Consideration of a Tradable Voucher to Reward Successful Antibiotic Development ,  September 29, 2014
  When a Patient Speaks,  September 25, 2014
  FDA Law Blog's 30 For 30 Hatch-Waxman 30th Anniversary Trivia: The Answers,  September 23, 2014
  Happy Anniversary Hatch-Waxman! Our 30 For 30 Trivia,  September 22, 2014
  Try Harder: The OIG Warns Drug Companies of Potential Liability for Copay Coupons,  September 22, 2014
  FAST Generics Act Would Amend the FDC Act to Address REMS/Restricted Access Programs and Biostudy Sample Availability,  September 18, 2014
  Thou Shalt Not: FDA Issues Two Guidances on ANDA Refuse-to-Receive Issues on the Eve of GDUFA Public Meeting,  September 17, 2014
  Court Upends FDAs Clinical Superiority Requirement for Granting Orphan Drug Exclusivity; Decision Leaves a Lot of Questions to Be Answered,  September 11, 2014
  Freaky Friday: After An Initial Loss, FDA Takes Home a Win in Generic PRECEDEX Litigation; Appeal Immediately Taken to the Fourth Circuit,  September 8, 2014
  Springboarding Off of an HP&M Citizen Petition, Connecticuts Attorney General Seeks to Dislodge Exclusivity Block on Generic NEXIUM,  September 8, 2014
  District Court Orders FDA to Recognize Orphan Drug Exclusivity for GRALISE; Rejects FDAs Requirement to Demonstrate Clinical Superiority of GRALISE,  September 7, 2014
  Court Orders Orange Book Patent Delisting in NUEDEXTA Infringement Litigation; But Whats It Good For?,  September 4, 2014
  The Generic Drug Labeling Carve-Out Scorecard,  September 2, 2014
  OGD Management Review Results in Forfeiture of Generic ACTONEL 180-Day Exclusivity Eligibility,  September 1, 2014
  FDA Puts Controls on Controlled Correspondence in the Agency's Latest GDUFA Offering,  August 27, 2014
  Who can Recall what FDAs Mandatory Recall Authority is? A U.S. District Court Could Not...,  August 26, 2014
  Final Rule on Branded Rx Drug Fee Treats All NDAs the Same, but IRS Might Consider a Special Rule for Pre-Hatch-Waxman Paper NDAs,  August 24, 2014
  In Generic PRECEDEX Litigation, Hospira Wins Temporary Restraining Order; Court Orders Recall of Generics, then Backtracks,  August 20, 2014
  Fuhgeddaboudit: FDA Takes a Different Road on Generic PRECEDEX and Issues Letter Decision Allowing ANDA Labeling Carve-Outs,  August 18, 2014
  FDAs Office of Generic Drugs Continues to Churn Out New and Revised Policies; Wants to Partner With Industry to Develop Best Practices,  August 18, 2014
  Rising to New Heights (And Sinking to New Lows): PDUFA, BsUFA, and GDUFA Fiscal Year 2015 User Fee Rates...And More,  August 14, 2014
  How Rare is the MC-to-PC Basis for Demonstrating that Two Drugs Are Not the Same Orphan Drug? Another Precedent Surfaces,  August 14, 2014
  Eisai Sues FDA Over NCE Exclusivity False Starts for BELVIQ and FYCOMPA,  August 10, 2014
  Biosimilars Guidance Has Sponsors Provide Information to Win Reference Product Exclusivity; Liberal Criteria Opens Door to Awarding More Exclusivities,  August 9, 2014
  FDA Was For PROCYSBI Orphan Drug Designation Based on Clinical Superiority Before It Was Against It . . . And Then For It Again,  August 3, 2014
  Pedigree Nouveau Must Be Uncorked,  July 30, 2014
  FDA Rejects Requests to Initiate Rulemaking for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions,  July 27, 2014
  FDA's Intervening NDA Approval Policy Strikes Again; Agency Denies Antares Petition on Methotrexate,  July 20, 2014
  FDA Refreshes 16-Year Old Informed Consent Guidance, Addresses Considerations for Vulnerable Populations,  July 17, 2014
  Yet Another Petition to FDA Says: Gimme My 5-Year NCE Exclusivity! But What's it to Ya?,  July 16, 2014
  Want to Unlock the 21st Century Cure? Hearing Witnesses Agree, Patient Input is Key,  July 16, 2014
  After a Draw in Court, Zogenix and Massachusetts Battle Over ZOHYDRO ER May Have to Proceed to a Penalty Shootout Round,  July 14, 2014
  FDA Issues GDUFA ANDA Amendment and PAS Guidances Explaining Implementation of Some of the More Complex Provisions of the User Fee Agreement,  July 10, 2014
  With Briefing Nearly Complete, Folks Get Set to Hunker Down for High-Stakes Rulings in Challenges to BPCIA Biosimilars Patent Dance Procedures,  July 9, 2014
  KV Lawsuit Involving MAKENA and Compounded 17p Concludes . . . . In Sopranos Style,  July 7, 2014
  New Compounding and Outsourcing Facility Guidance Issued Just in Time for July 4th Holidays,  July 3, 2014
  Compounders Can Relax, But Not Too Much,  July 3, 2014
  Is the Issuance of a Pediatric Written Request a Condition Precedent to FDA Awarding Pediatric Exclusivity? A New Citizen Petition Pushes FDA,  July 1, 2014
  Another Federal Court Rejects the ANDA RLD Theory of Liability: The Sixth Circuit Weighs In,  July 1, 2014
  FDA's New Interpretation of GDUFA: It Depends Upon What the Meaning of the Word New Is,  June 29, 2014
  Stirring the Pot of AIA Alphabet Soup: Now that Hatch-Waxman IPR Challenges Are Passé, Are PTAB CBM Patent Challenges the Next Big Thing?,  June 24, 2014
  Drug Lag Redux? Speeding Access to Already Approved Pharmaceuticals Act Would Require FDA to Take Cues from Europe,  June 22, 2014
  Sex Matters: Research for All Act Seeks to Facilitate the Research, Development, and Approval of Drugs With an Eye Towards Male and Female Differences,  June 19, 2014
  DALVANCE Gains Bonus Exclusivity; FDA Grants the First Period of GAIN Act,  June 19, 2014
  @FDALawBlog: Godot Returns: #FDAIssuesDraftGuidancesOnTwitter&Social Media,  June 17, 2014
  Gentlemen, We Can Rebuild the ANDA - Better, Stronger, Faster: FDA Issues Guidance on Quality ANDA Submissions,  June 12, 2014
  Another Good Reprint Practices Guidance, This Time Specific to New Risk Information,  June 9, 2014
  Relieving the Tension Between FDA's PLAIR Program and Hatch-Waxman: A New Paper Suggests A Remedy,  June 4, 2014
  FDA Issues Expedited Programs Final Guidance, Refines Breakthrough Therapy Designations and Accelerated Approval,  June 3, 2014
  The Ascension of FDA's September 19, 2011 Marketed Unapproved Drugs Compliance Policy Guide,  June 2, 2014
  Picking a Proprietary Name for a New Drug is No Simple Task - FDA Issues a Draft Guidance on Best Practices in Developing Proprietary Names,  June 1, 2014
  As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA's To-Do List Grows,  May 29, 2014
  After Years of Waiting, FDA Finally Lets Rip With Prescription PEG 3350 ANDA Withdrawal Proposal,  May 27, 2014
  21st Century Cures Initiative: HP&M's Frank Sasinowski Testifies at First Congressional Hearing,  May 21, 2014
  William Mitchell Law Review Celebrates 30 Years of the Hatch-Waxman Amendments,  May 21, 2014
  Mainers and FDC Act Preemption "In", and PhRMA and Foreign Commerce Clause "Out" in Dispute Over Drug Importation Law,  May 20, 2014
  FDA Scores an Initial Win in COPAXONE Litigation; When Will the Other Shoe Drop?,  May 18, 2014
  Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop,  May 14, 2014
  The Draft Guidance on Clinical Pharmacology Studies for Biosimilars - Is FDA Moving Forward, Sideways or Backwards by Retracing Steps Covered in the 2,  May 14, 2014
  Teva Sues FDA Over Failure to Substantively Respond to COPAXONE Citizen Petition,  May 8, 2014
  Enough Is Enough! Citizen Petition Issues a Clarion Call to FDA to Remove Ranbaxy's Roadblock to Generic Competition on Several Drugs,  May 6, 2014
  Favorable Ruling for Companies Defending Off-Label Promotion Cases,  May 5, 2014
  Boning Up: FDA Revisits Pre-MMA 180-Day Exclusivity and Addresses a New Scenario,  May 4, 2014
  FDA Denies Petitions Alleging Erroneous Triggering of NCE Exclusivity Start Date Before DEA Controlled Substance Scheduling Permitted Marketing,  May 1, 2014
  Tough Stain to Beat: Decades After Taking Enforcement Action Alleging Drug Status, FDA Says Most Peroxide Tooth Whiteners are "Cosmetics" (for now),  April 24, 2014
  A Second Company Asks FDA to Reconsider Denial of NCE Exclusivity for Approved FDC . . . and to Stay Application of the Agency's New Interpretation,  April 22, 2014
  Zogenix Prevails in Initial Challenge to Massachusetts Emergency Order Banning ZOHYDRO ER,  April 16, 2014
  GPhA Calls for US-EU Convergence in Biosimilar and Generic Medicine Regulation,  April 10, 2014
  FDA is Asked to Reconsider Denial of NCE Exclusivity for STRIBILD; Gilead Says FDA Erred in Not Applying the New (and Old) Interpretation,  April 9, 2014
  Zogenix Sues Massachusetts Over Order Banning ZOHYDRO ER; Alleges Ban is Unconstitutional,  April 8, 2014
  Another REMS Antitrust Lawsuit: Mylan Sues Celgene Over THALOMID and REVLIMID to Obtain Drug Product Sample,  April 4, 2014
  FDA Begins Implementation of the Drug Supply Chain Security Act: Calls for Comments and a Workshop,  April 02, 2014
  A Second Lawsuit Tests the BPCIA Biosimilars Patent Dance Waters,  April 1, 2014
  Limitations Imposed on Use of FDA Warning Letters,  March 25, 2014
  Independent Innovator and Repurposing Act Would Create New Patent Term Extension for Certain Biologics Patents,  March 25, 2014
  Perrigo Sues FDA Over Failure to Grant Therapeutic Equivalence Rating for Testosterone Gel 505(b)(2) NDA,  March 23, 2014
  The Numbers Are In! 2013 Was An Across-the-Board Record Breaker for Orphan Drugs,  May 20, 2014
  Snowball Effect: The Incidence of Premature Paragraph IV Certification Notice Grows,  March 18, 2014
  Lanham Act Decision Suggests That Marketing Pursuant to ANDA Approval Does Not Preclude Liability When FDA Later Reverses Its Decision,  March 11, 2014
  Generic Drug Labeling Preemption: The Flavor of the Day,  March 10, 2014
  FDA Expands and Clarifies Its Good Reprint Practices Guidance,  March 2, 2014
  Amarin Sues FDA After the Agency Denies 5-Year NCE Exclusivity for VASCEPA,  February 27, 2014
  FDA Denies 3 Petitions Seeking NCE Exclusivity for Combo Drugs, But Proposes to Reinterpret the Law for New NDAs,  February 23, 2014
  Purdue Pharma Petitions FDA to Apply ER/LA Requirements to IR Opioid Analgesics,  February 23, 2014
  Maybe There Is Such a Thing As a Free Lunch - VT Considers Allowing Drug & Device Makers to Again Provide In-Office Meals to Healthcare Professionals,  February 20, 2014
  BioMarin Snags the First Rare Pediatric Disease Priority Review Voucher with VIMIZIM Approval,  February 17, 2014
  Like a Bad Penny, Pre-MMA 180-Day Exclusivity Keeps Turning Up!,  February 17, 2014
  The Rollout: FDA's Mission Critical ANDA Undertaking,  February 12, 2014
  FDA Issues Receipt Date Guidance for Electronic Submissions; Make Your Submissions Before Midnight With Time to Spare,  February 11, 2014
  D.C. Circuit Rules That FDA Can Regulate Autologous Stem Cells,  February 5, 2014
  The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act?  February 4, 2014
  GPhA Blasts FDA's Generic Drug Labeling Proposal as Unworkable; Depicts a Dystopian Future,  February 4, 2014
  Broken Economic Incentives Require New Business Models for Antibiotics, Says CDC Antimicrobial Resistance Working Group Member,  February 3, 2014
  AstraZeneca Wins One Battle, But Loses Another (And Perhaps the War) on SYMBICORT Patent Term Extension,  February 2, 2014
  FDA's Office of Generic Drugs Embarks on Massive Effort to Address Post-GDUFA Stakeholder Transparency Concerns,  January 31, 2014
  Lawmakers Express Grave Concerns with Generic Drug Labeling Proposal; Demand Answers from FDA,  January 22, 2014
  Improving the Yield on ANDA Submissions: FDA Wants to Hear Industry's Concerns and Provide Guidance on How to Build a Better ANDA,  January 22, 2014
  FDA Seeks Comment on Generic Dexmedetomidine HCl Injection (PRECEDEX) Approval,  January 16, 2014
  Godot Finally Arrives: At Long Last, FDA Issues Draft Guidance On Submissions For Interactive Social Media,  January 16, 2014
  Weekend and Holiday ANDA Tentative (or Final) Approvals and 180-Day Exclusivity: We Won't Know if Anyone is Swimming Naked Until the Tide Goes Out,  January 14, 2014
  FDA Touts the Benefits of Outsourcing Facility Registration to State Officials and Hospital Purchasers of Compounded Medications,  January 9, 2014
  DC Circuit Reinstates KV Lawsuit Over MAKENA and Compounded 17p in Light of Cook Decision and DQSA,  January 9, 2014
  The Federal Circuit is Slated to Consider an Appeal of the First BPCIA Biosimilars "Patent Dance" Decision,  January 6, 2014
  The Federal Circuit Wades into FDC Act Preemption and Intended Use in RevitaLash Decision,  January 2, 2014
  New Legislation Would Legalize Personal Importation of Certain Foreign Drugs,  December 30, 2013
  Office of Generic Drugs "Super Office" Becomes a Reality; New "Office of Generic Drug Policy" Will Handle Hatch-Waxman Issues,  December 25, 2013
  Amgen Advocates for Distinguishable Non-Proprietary Names in Substantial Comments to GPhA and Novartis Biosimilar Naming Citizen Petitions,  December 22, 2013
  Royal Flush? Trade Groups Challenge a Second Drug Stewardship Program; This Time the Target is King County, Washington,  December 17, 2013
  A Hard Pill to Swallow? In Transit for a Couple of Years, FDA Finally Coughs Up Draft Guidance on Physical Attributes of Generic Tablets and Capsules,  December 15, 2013
  Breaking the Silence: Rush Bill Would Curb Drug Patent Settlement Agreements,  December 13, 2013
  ADAPT Act Would Create a New Limited Population Approval Pathway for Antibiotics and Antifungals,  December 13, 2013
  Drug Shortage Plaintiffs Fail to Demonstrate Injury, Causation,  December 10, 2013
  Otsuka Alleges Premature Notice From a Repeat Offender in SAMSCA Patent Infringement Case,  December 9, 2013
  Diary of a Hatch-Waxman Addict: Day 3,655 - What About Untimely (Late) Notice?,  December 9, 2013
  Escape Hatch: New Legislation Seeks to Provide a Way Out for Some Companies Subject to GDUFA User Fees,  December 3, 2013
  FDA is Petitioned Twice More to Delay Start of Hatch-Waxman Exclusivity,  December 2, 2013
  Surprise! FDA Quickly Issues Compounding Draft Guidances,  December 2, 2013
  PTO Dismisses PTE Application in "Reverse Photocure" Case; Moves One Step Closer to a Showdown in Court?,  November 25, 2013
  One Sponsor's Failure is Another Sponsor's Fortune: The Importance of Timely Listing (and Challenging) Orange Book Patents,  November 25, 2013
  Along with the Track and Trace Legislation, Senate Passes the Compounding "Drug Quality and Security Act": Now Awaiting President Obama's Signature,  November 19, 2013
  Can It Be True? Has Congress Finally Tracked Down a Federal Track-and-Trace System?,  November 18, 2013
  HDMA's 2013 Track-and-Trace Conference: Right Here Waiting for H.R. 3204,  November 17, 2013
  FDA Proposes a Rule that Would Undercut Generic Drug Preemption,  November 12, 2013
  FDA Issues Proposed Rule and Strategic Plan to Address Drug Shortages,  November 5, 2013
  Game of Thrones: FDA is Once Again Petitioned on Biosimilar Naming; Novartis Wants Shared INNs,  October 31, 2013
  Trends in Personalized Medicine  October 2013
  FDA Lays Out Post-GDUFA Implementation Plans: A Brave New World or A Modern Utopia in the Making?,  October 30, 2013
  FDA Makes Zohydro ER First Approved Single-Entity Hydrocodone Analgesic, First ER/LA Opioid to Contain Hydrocodone & First ER/LA Opioid w/New Labeling,  October 29, 2013
  FDA Prevails in Challenge to Generic ACETADOTE Approval; Court Grants Summary Judgment,  October 28, 2013
  FDA Largely Denies Citizen Petition on Single, Shared REMS System, But Outlines Agency Standards and Processes,  October 21, 2013
  FDA's House Rules on 505(b)(2) NDA Choice of Listed Drug; How Does it Affect Dealer's Choice?,  October 17, 2013
  Repairing the U.S. Cancer Care Delivery System: Should It Include a New Exclusivity Incentive?,  October 16, 2013
  Biosimilar Substitution Bill Opposition Strikes Gold in California: Governor Brown Vetoes the Measure,  October 15, 2013
  As Maine's Drug Importation Law Goes Into Effect, State Seeks Dismissal of Lawsuit to Block Implementation,  October 9, 2013
  The Shutdown: An Update on FDA Activities,  October 7, 2013
  As Partial Government Shutdown Kicks In, FDA's Foods Program Is Hardest Hit,  October 1, 2013
  National Rx Track and Trace System Could Soon Be a Reality - House Passes HR 3204,  September 30, 2013
  Center for Legal Policy Report Takes Aim at FDA's Regulation of Autologous Stem Cell Procedures,  September 29, 2013
  Money Has a Way of Changing People: The UFAization of FDA's Office of Generic Drugs,  September 26, 2013
  FDA's Fifth Annual Report to Congress on 505(q) Citizen Petitions: Something Old, Something New, Something Borrowed, FDA is Still Blue,  September 25, 2013
  Act II, Scene II: A Rose By Any Other Name Would Smell as Sweet? "No!" Says GPhA in Citizen Petition to FDA on Biosimilar Naming,  September 19, 2013
  FDA Grants PROP Petition (in Part), Proposes New Labeling and Requires Post-Marketing Studies for ER/LA Opioid Analgesics,  September 16, 2013
  You Can't Handle the Truth! Code Orange Court Dismisses Lanham Act-Orange Book Therapeutic Equivalence Rating Complaint on Primary Jurisdiction Ground,  September 15, 2013
  Not In Our Backyard! Pharmacists and Trade Groups Sue to Block Implementation of Maine Drug Importation Law,  September 12, 2013
  The Biosimilars State Legislation Scorecard,  September 4, 2013
  Alameda County Drug Take-Back and Disposal Ordinance Not Unconstitutional Says Federal Judge,  September 3, 2013
  Public Shaming: FDA Edges Closer to Citizen Petition Denial for Intent to Delay Generic Drug Approval, But Prefers to Pass the Buck on Enforcement,  August 28, 2013
  Lifting the Veil on FDA Subpart H Surrogate Endpoint Approvals,  August 27, 2013
  First Post-FDAAA "New Active Ingredient" Election and Grant of NCE Exclusivity Made With the Approval of FETZIMA,  August 25, 2013
  FTC Seeks to File (Again) Amicus Brief in EFFEXOR XR No-AG" Agreement Antitrust Case; Plaintiffs in Similar LAMICTAL Case Seek Reconsideration,  August 20, 2013
  Eisai Says FDA Erroneously Triggered NCE Exclusivity Start Dates Before DEA Controlled Substance Scheduling Permitted Marketing,  August 11, 2013
  New Legislation Seeks to Provide 5-Year NCE Exclusivity For Certain Combination Drugs,  August 5, 2013
  GAO Report on Drug Compounding: Lack of Both Clear Authority and Reliable Data Compounds FDA's Inability to Act,  August 4, 2013
  FDA Announces Fiscal Year 2014 User Fee Rates; They're Movin' On Up!,  August 1, 2013
  Superior Court of PA Delivers Quadruple Whammy in Metoclopramide Failure-to-Warn Preemption Decisions; Gives RLD Theory of Liability Some Legs,  July 30, 2013
  Breakthrough Therapy Designation: Stakeholders Discuss the Program One Year Later,  June 28, 2013
  FDA Resolves 180-Day Exclusivity Forfeiture for Tentative Approvals that Occur on the 30-Month ANDA Submission Anniversary Date,  July 25, 2013
  FDA Racks Up a Circuit Court Loss in Imported and Unapproved Thiopental Sodium Case; Will It Jeopardize FDA's Drug Shortage Program?,  July 23, 2013
  Fecal Microbiota Transplantation: FDA Announces Limited Enforcement Discretion,  July 23, 2013
  FDA SOS: New Bill Would Exempt FDA User Fees From the Ravages of Sequestration,  July 18, 2013
  In Case You (Like Everyone) Missed It - The Administrative Conference of the United States is Back,  July 17, 2013
  FDA Continues to Solicit Comments on Drug Supply Chain Issues,  July 16, 2013
  A Punt Return, Not a Fumble Return, in the Second FDA Resolution of a 180-Day Exclusivity Punt Case,  July 15, 2013
  Lies, Damned Lies, and Statistics: Another Report on Drug Patent Settlement Agreements,  July 11, 2013
  New IMS Report Ups the Ante on Drug Patent Settlement Agreement Savings,  July 9, 2013
  Updated Analysis Shows Patent Use Codes Have Nearly Tripled Since August 2003,  July 8, 2013
  In an Unusual Move, FDA Denies RLD Designation for an Orange Book Listed Drug,  July 7, 2013
  FDA Moves to Blunt the Effects of the Supreme Court's Mensing and Bartlett Generic Drug Preemption Decisions,  July 5, 2013
  FDA Precedent on Tramadol NDA Resubmission Shows Agency Efforts to Dull the Pain of a Statutory Prohibition,  July 2, 2013
  FDA Provides Insight Into Breakthrough Therapy Designation, Consolidates Guidance for Expedited Programs,  July 1, 2013
  Federal District Court Strikes Blow Against RICO Challenges to Drug Co-pay Coupons,  June 26, 2013
  Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!,  June 25, 2013
  Supreme Court Rules in Bartlett Generic Drug Preemption Case; Says State-Law Design-Defect Claims That Turn on a Drug Warnings Adequacy are Preempted,  June 24, 2013
  Supreme Court Rules in ANDROGEL Patent Settlement Agreement Case; Holds Agreements are Subject to Antitrust Scrutiny, But Not Presumptively Unlawful,  June 17, 2013
  Proposed Draft of House Compounding Legislation Released, Comments Wanted by Thursday June 20, 2013,  June 17, 2013
  House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action Deadlines,  July 13, 2013
  Striding Towards Greater Access to Clinical Trials Data and Results,  June 13, 2013
  FDA Issues Final Orphan Drug Regulations,  June 12, 2013
  Obama Administration Gives Up Fight Over PLAN B After Second Circuit Issues Split Decision on Motion for Stay Pending Appeal,  June 11, 2013
  One Step Closer? House Passes a National Rx Track and Trace System,  June 10, 2013
  FDA Issues Guidance Regarding Contract Manufacturing Quality Agreements,  June 9, 2013
  Momenta Spars with Amphastar; Says Federal Circuit's LOVENOX Safe Harbor Decision Must be Taken Up by the Supreme Court,  June 5, 2013
  A Fumble Return, Not a Punt Return, in the First FDA Resolution of a 180-Day Exclusivity Punt Case,  June 4, 2013
  Bayer Joins the Combo Drug NCE Challenge Club; Petitions FDA for 5-Year Exclusivity for NATAZIA,  May 29, 2013
  FDA is Asked to Deviate From ANDA "Exception Excipient" Policy for Generic VFEND Injection; Precedent Indicates Agency Will Remain Firm,  May 21, 2013
  While We're Waiting on Bartlett, Some New Preemption Challenges to Consider,  May 20, 2013
  FDA Determines Original OPANA ER Not Discontinued for Safety Reasons; Decision Affirms Case-by-Case Review,  May 13, 2013
  Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition  May 2013
  Generic and Innovator Drugs: The Next Generation,  May 7, 2013
  FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate,  May 5, 2013
  False Friends: FDA's "Gift" on NESINA - Present or Poison? It May Depend on Which Hatch-Waxman Language is Spoken,  May 2, 2013
  FDA to Reconsider Approval of Generic BAYTRIL; Court Gives Importance to Unresolved Citizen Petition; Will the Decision Affect FDA Petition Procedures,  April 30, 2013
  DC Circuit Rules for FDA in SEROQUEL Exclusivity Case; AstraZeneca Not Entitled to 3-Year Exclusivity,  April 29, 2013
  Senate's HELP Committee Releases Draft Compounding Legislation; Seeks Stakeholders' Written Comments by May 3, 2013,  April 29, 2013
  Tracking and Tracing Congress' New Track and Trace Bills,  April 25, 2013
  Court Rules in Novel False Claims Act Case Where One Pharmaceutical Company Sues Another,  April 24, 2013
  President's 2014 Budget Continues Push to Curb Patent Settlement Agreements, Shorten Biologics Exclusivity; Biologics Exclusivity Faces Opposition,  April 11, 2013
  Court Orders FDA to Approve OTC Emergency Contraception w/o Restrictions-Describes Intervention by Sebelius as Unprecedented & Politically Motivated,  April 7, 2013
  Discord Among Accord and Acorda Over AMPYRA Biostudy Sample Leads to Restricted Distribution Antitrust Lawsuit,  April 2, 2013
  Timing is Everything! . . . In Life and In Hatch-Waxman; Fun With 180-Day Exclusivity Forfeiture,  March 31, 2013
  Admin Law Trumps "Immutable Laws of Science," Says DC Circuit Challenge Over Generic Derma-Smoothe Approvals; Hill Appeals & Denial Quickly Follows,  March 28, 2013
  The Big Day Approaches: Supreme Court to Hear Oral Argument in ANDROGEL Drug Patent Settlement Agreement Case,  March 24, 2013
  Preemption, Preemption, and More Preemption - A Cert Petition, a Circuit Court Decision, and the Upcoming Battle in Mutual v. Bartlett,  March 18, 2013
  FDA Releases Revised Draft Guidance for "Formal Dispute Resolution: Appeals Above the Division Level",  March 15, 2013
  KV Says "Heckler/Chaney Defense" is Inapplicable in Appeal Concerning Compounded 17P and Orphan Drug MAKENA,  March 13, 2013
  FTC Chimes In On Restricted Distribution and Generic Competition; Files Amicus Brief in TRACLEER Case,  March 12, 2013
  Forty-Eight State and Territorial Attorneys General Call for Tamper-Resistant Versions of Generic Prescription Pain Killers,  March 11, 2013
  Antitrust Law Must Play Traditional "Magna Carta of Free Enterprise Role, Say Generic Defendants in Lawsuit Over Restricted Distribution,  March 6, 2013
  Rebel Without a Cause: Sun Sues FDA Over 180-Day Exclusivity for Generic ZOMETA,  March 3, 2013
  Inter Partes Review and Forfeiture of 180-Day Generic Drug Exclusivity,  February 28, 2013
  U.S. Supreme Court Asked to Review Hatch-Waxman "Safe Harbor" LOVENOX Method Patent Case,  February 25, 2013
  Will New Recommendations From NIH Curb Use of the Animal Efficacy Rule?,  February 20, 2013
  OIG Report Calls Into Question Effectiveness of FDA's REMS Program,  February 18, 2013
  Don't Call It a Counterfeit, and Other Recommendations from the IOM Report on Falsified and Substandard Drugs,  February 15, 2013
  The Orphan Drug Act: 30 Years and Still Going Strong!,  February 13, 2013
  FDA Denies Petition to Regulate Prescription Prenatal Vitamins Containing Folic Acid under an Rx Monograph,  February 12, 2013
  A New Wrinkle in Generic ACTOS 180-Day Exclusivity; What Might it Mean for Post-MMA Exclusivity?,  February 11, 2013
  Function Over Form or Form Over Function? Two Petitions Challenge FDA's NCE Exclusivity Approach for Combination Drugs,  February 10, 2013
  Insanity? A Nearly Unchanged Preserve Access to Affordable Generics Act is Introduced in Congress,  February 5, 2013
  From the Bleacher Seats: Amici Weigh in for the FTC in ANDROGEL Drug Patent Settlement Agreement Supreme Court Case,  February 4, 2013
  Reissue Patents and FDA's Hidden Policy on 180-Day Exclusivity: A Vestigial Remnant or More?,  February 3, 2013
  Actelion Seeks Judgment on the Pleadings in Lawsuit Over Restricted Distribution and Biostudy Product Availability,  January 23, 2013
  FDA's Fourth Annual Report to Congress on 505(q) Citizen Petitions; Agency Continues to Express Concerns About the Use and Effects of 505(q),  January 21, 2013
  FTC Issues FY 2012 Patent Settlement Report; Says a Record Number of Agreements Filed With "Pay-for-Delay" Potential,  January 17, 2013
  Biosimilar Substitution: Battles are Brewing at the State Level,  January 17, 2013
  FDA Sets GDUFA Fiscal Year 2013 Facility User Fee Rates; Fewer Facilities Result in Higher Rates,  January 16, 2013
  FDA Considering Alternative Approval Pathway,  January 15, 2013
  DC District Court Sews Up Generic VANCOCIN Litigation; Decision Merely Refines and Adds New Details to Previous Preliminary Injunction Decision,  January 14, 2013
  Patient Power in Orphan Drugs,  January 13, 2013
  FDA Issues “One-Stop Shop” Draft Guidance Document on Post-MMA 180-Day Exclusivity,  January 13, 2017
  New FDA Draft Guidance "Abuse-Deterrent Opioids - Evaluation and Labeling" to Permit Abuse-Deterrent Labeling Claims,  January 10, 2013
  When is 5-Year NCE Exclusivity Less Than 5 Years?,  January 9, 2013
  A Pre-MMA 180-Day Exclusivity Punt? What Gives?,  January 8, 2013
  FDA and Ranbaxy Prevail in Dispute Over Generic DIOVAN 180-Day Exclusivity; Court Grants Motions for Summary Judgment,  January 2, 2013
  Trade Groups Sue Alameda County Over Drug Take-Back and Disposal Ordinance,  December 19, 2012
  FDA Releases Draft Guidance on Enrichment Strategies for Clinical Trials,  December 18, 2012
  "No-AG" Agreements are Not "Reverse Payments" Subject to Antitrust Scrutiny Says District Court in LAMICTAL Litigation,  December 17, 2012
  "Carcinogen-Free" Label Program Proposed in House Bill ,  December 12, 2012
  A Deep Dive Into the Second Circuit's Caronia Decision, Potential Next Steps, and Potential Enforcement Fallout,  December 12, 2012
  More Legislation Introduced to Strengthen State Cooperation and Federal Oversight of Compounding Pharmacies,  December 10, 2012
  Actelions Preemptive Strike Over REMS and Biostudy Product Availability Draws Antitrust Counterclaims, Another Drug, and Another Company Into the Mix,  December 5, 2012
  Endo Sues FDA; Seeks Court Orders for FDA Determinations on the Discontinuation of "Old" Opana® ER and With Respect to Approved and Pending ANDAs,  December 2, 2012
  ASBM Says Distinct USAN Names for Biosimilars are Needed,  November 29, 2012
  Apotex Seeks Exclusivity-Triggering Court Decision in Declaratory Judgment Action Over Generic BENICAR Patent,  November 26, 2012
  "Product Hopping" Antitrust Lawsuit Takes on a Heightened Profile with Proposed FTC AmicusBrief,  November 25, 2012
  FDA and California Board of Pharmacy Talk Pedigree at Annual HDMA Track and Trace Conference,  November 18, 2012
  Cumberland Sues FDA After the Agency Denies Citizen Petition and Approves Generic ACETADOTE,  November 16, 2012
  With Briefing Over, Post-Mensing Generic Drug Preemption Appeal Awaits Word From the Supreme Court,  November 14, 2012
  The Toxin in Ackee: Naturally Occurring? Added? Does It Matter?,  November 13, 2012
  A Congressional Hearing: "The Fungal Meningitis Outbreak: Could It Have Been Prevented?" Is Scheduled for Wednesday, November 14, 2012,  November 12, 2012
  FDA Presses "Heckler Defense" in Appeal of Unapproved Thiopental Sodium Death Row Inmate Case,  November 12, 2012
  Does a Hatch-Waxman Patent Delisting Counterclaim Terminate a 30-Month Litigation Stay?,  November 8, 2012
  "New" CDER Exclusivity Board Focuses on Clarity and Consistency of Exclusivity Decisions,  November 6, 2012
  Congressman Markey Introduces Legislation Increasing Regulatory Oversight of Pharmaceutical Compounding,  November 5, 2012
  Excuses, Excuses! A Round-Up of Exceptions Under the Failure to Obtain Timely Tentative Approval 180-Day Exclusivity Forfeiture Provision,  November 1, 2012
  Court Orders ANDA Approval in Pre-MMA 180-Day Exclusivity Case; Decision Appears to Have Post-MMA Implications,  October 29, 2012
  Our GDUFA Cup Runneth Over! FDA Sets Several FY 2013 User Fee Rates,  October 25, 2012
  New Track-and-Trace Legislation: The Real Deal or Another False Start?,  October 25, 2012
  Rehearing Sought in Hatch-Waxman Safe Harbor" Case; Plaintiffs-Appellees Contend Fed Circuit Panel Decision Expands "Safe Harbor" Into a "Safe Ocean",  October 23, 2012
  The End of the Road: Franck's Compounding Case is Moot,  October 16, 2012
  "No-AG" Agreements are Anticompetitive, Says the FTC for a Second Time,  October 15, 2012
  Fungal Meningitis Outbreak Prompts Calls for Greater Regulation of Compounders,  October 10, 2012
  Actelion Preemptively Sues Generic Companies Over REMS and Biostudy Product Availability Issues; Case Could be a Bellwether for Future Efforts,  October 9, 2012
  U.S. Supreme Court is Again Asked to Take Up Drug Patent Settlement Agreements; This Time It's ANDROGEL,  October 8, 2012
  What's the Hang-up? Apotex Sues FDA Over Compliance Failure That's Stalling ANDA Approvals,  October 4, 2012
  FDA Sued Over Generic DIOVAN 180-Day Exclusivity; Lawsuit Takes Issue With FDA Forfeiture Decision and "Trust Me" Approach to Exclusivity Decisions,  October 3, 2012
  New Legislation Would Provide Exclusivity Add-on for Significant Drug Combinations,  October 2, 2012
  White House Releases Major Paper on Propelling Innovation in Drug Development and Recognizes HP&M's Frank Sasinowski for Contributions,  September 27, 2012
  Another Orphan Drug Battle; Depomed Sues FDA Over GRALISE Orphan Drug Exclusivity,  September 26, 2012
  Legislative Fix Would Allow FDA to Collect GDUFA User Fees,  September 19, 2012
  Patent Settlement Agreements: The Next Barrage,  September 17, 2012
  Revised Formula Yields a Lower Priority Review Voucher User Fee of $3,559,000; Will That Help Spark Greater Interest in the Program?,  September 12, 2012
  The Brand-Name Side of the Exclusivity Equation; Exclusivity Under Fire,  September 10, 2012
  KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17P,  September 6, 2012
  The Coming 505(q) Citizen Petition Cliff and Some Interesting Petition Strategies,  September 4, 2012
  The Obesity Epidemic: FDA's Growing Waistline!,  September 3, 2012
  Hot Ticket Item - Patent Settlement Agreement Challenges,  August 29, 2012
  IOM Issues Report on "Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network",  August 27, 2012
  FDA Gears Up for GDUFA Implementation and ANDAgeddon,  August 23, 2012
  Congressional Interest in FDA Remains High, Even After the Enactment of FDASIA,  August 20, 2012
  Push for 12-Year Biologics Exclusivity in TPP Agreement Continues as the Next Round of Negotiations Approaches,  August 16, 2012
  FDA is Sued Again Over Pre-MMA 180-Day Exclusivity; This Time the Drug is Generic ACTOS,  August 15, 2012
  Running Into a Glass Door (or Window); a Problem With the New "Window ANDA" Forfeiture Provision,  August 12, 2012
  FDA Rescinds Orphan Drug Exclusivity for Wilate; A First-of-its-Kind Decision,  August 8, 2012
  Federal Circuit Rules That Hatch-Waxman "Safe Harbor" is Quite Broad in Dispute Over Enoxaparin Method Patent,  August 7, 2012
  "Big RLD" Versus "Little rld" - What's the Difference?,  August 6, 2012
  Supreme Court Asked to Take Up Post-Mensing Bartlett Generic Drug Labeling Preemption Decision,  August 2, 2012
  PDUFA V Begins With Relatively Modest Changes to User Fee Rates,  July 31, 2012
  The Regenerative Sciences - FDA Court Struggle Ends . . . For Now,  July 25, 2012
  STOPP Act Would Establish New Requirements for Tamper-Resistant Drugs,  July 24, 2012
  Lack of Regulatory Guidance Fatal to Some, But Not All Claims in AMP False Claims Act Case,  July 18, 2012
  New Director Tapped to Head FDA's Office of Generic Drugs,  July 13, 2012
  FDA Approves Class-Wide Opioid REMS After More Than Three Years,  July 12, 2012
  FDASIA Enacted; HP&M Issues Detailed Summary and Analysis,  July 11, 2012
  Judge Supports FDA Decision Approving Generic Bromfenac,  July 10, 2012
  DC District Court Rules for FDA in Generic SEROQUEL Exclusivity Case; Grants Motion for Summary Judgment,  July 9, 2012
  FDA Sued for Abrogating MAKENA Orphan Drug Exclusivity; Suit Alleges FDA is Turning a Blind Eye to Compounded 17P and Bowing to Political Pressure,  July 8, 2012
  FDA Announces Intent to Take Enforcement Action With Respect to Certain Marketed Unapproved Oxycodone Drug Products; Denies Lannett "Grandfather Drug,  July 5, 2012
  Presidential Commission Seeks Comment on the Development of Medical Countermeasures for Children,  June 28, 2012
  FDA Petitioned on 180-Day Exclusivity Forfeiture for Tentative Approvals that Occur on the 30-Month ANDA Submission Anniversary Date,  June 27, 2012
  On the Eve of PDUFA Reauthorization, DC District Court Strikes Down FDA Interpretation of PDUFA,  June 25, 2012
  FDA Once Again Departs From Conventional Bioequivalence Metrics and Sets Partial AUC Parameters for Generic ADDERALL XR,  June 24, 2012
  A 505(b)(2) NDA in Search of a Basis for Submission and Approval; the Curious Case of Morphine Sulfate Oral Solution,  June 21, 2012
  When Can't a "Listed Drug" Serve as a Reference Product for a 505(b)(2) Application?,  June 19, 2012
  New Study Examines Citizen Petitions; Concludes that Petitions are on the Rise and that 505(q) Has Been Unsuccessful,  June 17, 2012
  FDA Makes Institutional Review Board Draft Guidance Available,  June 14, 2012
  "Bring Out Your Dead" Says OGD in a Pre-GDUFA House Cleaning Move as the Agency Prepares for ANDAgeddon,  June 13, 2012
  FTC Commissioner Objects to Certain Provisions in Senate FDA User Fee Reauthorization Legislation,  June 5, 2012
  House Passes FDA Reform Act of 2012; Next Up - Conference Committee,  May 31, 2012
  Pennsylvania District Court Issues an XL Decision in WELLBUTRIN XL Antitrust, Sham Citizen Petition Case,  May 30, 2012
  Making the House FDA Reform Act of 2012 PAYGO Compliant - Are Expedited 505(q) Citizen Petition Responses the Answer?,  May 28, 2012
  U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House Bill,  May 25, 2012
  FDA's PLAIR Program Collides With Hatch-Waxman,  May 23, 2012
  Abbott Petitions FDA on Biosimilars; Argues Fifth Amendment Takings Clause ,  May 17, 2012
  Decisions, Decisions, Decisions! Our Updated Labeling Carve-Out Citizen Petition Scorecard,  May 16, 2012
  New Reports on FDA Drug Approval Performance Emerge as House Committee Considers User Fee Reauthorization Legislation,  May 10, 2012
  Defendants Rack Up Another State Court Win in Mensing and RLD Liability Theory Decisions,  May 8, 2012
  Updated House Energy & Commerce UFA Bill Would Shorten FDA's 505(q) Petition Response Timeframe; Require Timely Responses to RLD Withdrawal Petitions,  May 7, 2012
  CMS Delays Sunshine Act Data Collection Until January 2013,  May 4, 2012
  New Bill Would Change Clinical Trial Registry Reporting Requirements and Enforcement Measures for Studies Supported by Federal Grants,  May 3, 2012
  GAO Report Says That FDA Has Met Most PDUFA Performance Goals; Agency Plans to Take Steps to Address Lingering Stakeholder Concerns,  May 2, 2012
  FDA Finalizes Rules on Clinical Investigator Disqualification,  May 1, 2012
  Eleventh Circuit Rules Against the FTC in ANDROGEL Patent Settlement Appeal; Sen. Bingaman Pushes for Legislative Remedy,  April 30, 2012
  Congress Introduces the PATIENTS' FDA Act to Increase Transparency, Efficiency, and Predictability,  April 20, 2012
  Senate and House Bills Seek to Legislatively Overturn the Supreme Courts Mensing Decision,  April 19, 2012
  Absolutely, Totally, and in All Other Ways Inconceivable? Nope, Says the Federal Circuit in YASMIN Hatch-Waxman Method Patent Litigation,  April 18, 2012
  Supreme Court Rules in Patent Use Code Case; Reverses Federal Circuit Decision,  April 17, 2012
  The Other Shoe Drops: ViroPharma Sues FDA - Challenges Denial of 3-Year Exclusivity and ANDA Approvals,  April 16, 2012
  Franck's Lab Takes FDA to Task in the 11th Circuit; Picks Off Each of the Government's Arguments,  April 12, 2012
  FDA Denies ViroPharma Citizen Petition and Approves Generic VANCOCIN; ViroPharma Lawsuit to Follow,  April 10, 2012
  First Dust Up Over Generic PROVIGIL 180-Day Exclusivity Quickly Put on Hold With TRO/PI Motion Withdrawal, But is Followed Up With a Second Lawsuit,  April 5, 2012
  FDA's Third Annual Report to Congress on 505(q) Citizen Petitions; Agency Says the Jury is Still Out on the Petition Law, But There are Concerns,  April 3, 2012
  Pallone Bill Takes an "Oscar Rogers Approach" to 180-Day Exclusivity Forfeiture and FDA's Office of Generic Drugs: FIXIT!,  April 1, 2012
  FDA Extends Deadline for Reporting Samples Under ACA,  March 30, 2012
  AstraZeneca Loses TRO Bid in Second Generic SEROQUEL Lawsuit,  March 29, 2012
  Leahy Bill Would Legislatively Undo the U.S. Supreme Court's Mensing Decision,  March 29, 2012
  Nonprofit Groups Prevail in Lawsuit Against FDA Over Subtherapeutic Uses of Penicillin and Tetracyclines in Animal Feed,  March 27, 2012
  Another Loss in Court for FDA; Judge Leon Rules for Death Row Inmates in Unapproved Thiopental Sodium Case,  March 27, 2012
  D.C. District Court Denies Preliminary Injunction In Generic SEROQUEL Litigation; Dismisses "Premature" Lawsuit Without Prejudice,  March 26, 2012
  You Had Us At "Biosimilars," FDA; Agency Ties Up Yet Another Biosimilars Loose End With Petition Response Concerning Certain "Biological Drugs",  March 21, 2012
  "RLD Theory of Liability" Continues to Fall Flat; Multiple Court Decisions Build Momentum in Generic Drug Failure-to-Warn Preemption Litigation,  March 19, 2012
  Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs: Cataloging FDA's Flexibility in Regulating Therapies for Persons with Rare  March 2012
  AstraZeneca Sues FDA Over Generic SEROQUEL Labeling Carve-Out Issue After FDA Issues Non-Response Citizen Petition Denial,  March 13, 2012
  His Name was RICO, He Wore a Diamond: Lawsuits Allege that Coupons and Savings Programs for Brand-Name Drugs Violate RICO, Antitrust Law,  March 12, 2012
  FDA Cements "It's Our Party and We'll Punt if We Want to" Stance on 180-Day Exclusivity Failure to Obtain Tentative Approval Forfeiture Decisions,  March 11, 2012
  VA Issues Final Rule on Promotion by Pharmaceutical Company Representatives,  March 7, 2012
  A Trio of Reports Discuss the Benefits of the Pediatric "Carrot and Stick" Statutes, the Orphan Drug Act, and Hatch-Waxman,  March 6, 2012
  On-Again Off-Again Third Category of Drugs is On Again at FDA; Simultaneous Rx and OTC Marketing Also Up for Debate,  February 29, 2012
  FDA Flexes New Enforcement Muscle; Issues Warning Letter for Failure to Meet Required Postmarketing Study Milestone Dates,  February 28, 2012
  YASMIN Case: Is it Conceivable (or Not) that Hatch-Waxman Method Patent Infringement Lawsuits Limited to Info in the "Indications & Usage",  February 22, 2012
  Seeking a Second Bite at the Apple? Lannett Petitions FDA on the "Grandfather" Status of Morphine Sulfate,  February 20, 2012
  FDA Wraps Up Responses to 2003 & 2004 Petitions on "Biosimilars"; Denies Outstanding Requests,  February 16, 2012
  BMJ Article on Clinical Trial Reporting Foments Discontent on Capitol Hill,  February 15, 2012
  FDA Releases New Guidance on ClinicalTrials.Gov Statement in Informed Consent Documents,  February 13, 2012
  Full Circle: Rush Bill Would Make Most Patent Settlement Agreements Unlawful,  February 13, 2012
  "Soon" Has Finally Come; FDA Issues Three Highly Anticipated Biosimilars Draft Guidances,  February 10, 2012
  The Coda in the ANGIOMAX Symphony; Approaching Fine (the End),  February 9, 2012
  The Year of the Orphan; Orphan Drug Designations and Approvals Hit All-Time High in 2011,  February 8, 2012
  DC District Court Grants FDA Summary Judgment in Generic LOVENOX Dispute,  February 7, 2012
  Drug Shortage Prevention Act Seeks to Improve Communication and Expedite Review of Drugs in Shortage,  February 3, 2012
  GAO Report Criticizes FDA on Antibiotic Labeling; Finds No Evidence of Encouraged Innovation,  February 1, 2012
  PTO Challenged After Denying a Patent Term Extension Based on First Commercial Marketing or Use Grounds,  January 31, 2012
  A New Hatch-Waxman DJ Jurisdiction Decision . . . . And an Added Twist,  January 24, 2012
  Leap Year and Hatch-Waxman - An Unusual Conundrum Years in the Making,  January 23, 2012
  FDA Sends User Fee Pacts to Congress; Proposed Generic Drug User Fee Statute Includes Some Unique Provisions,  January 18, 2012
  FDA Denies Petition Seeking to Add Application Information to Drug Labels,  January 12, 2012
  Senators Hatch and Harkin Request that FDA Withdraw Draft NDI Guidance,  January 10, 2012
  A Federal Court Win on the RLD Theory of Liability; More of Moore Will Likely be Called For,  January 9, 2012
  "Size Matters," Says FDA, When it Comes to Generic Drug-RLD Sameness,  January 4, 2012
  ULTRA Bill Introduced in the House; Legislation Seeks to Permit Broader Use of Scientific Data to Support Surrogate Endpoints for "Ultra Orphan" Drug,  January 2, 2012
  GAO Report Finds That FDA Needs Increased Authority to Address Shortages,  December 19, 2011
  Revelations: FDA's Perspective on Drugs Marketed Pursuant to a Pending DESI Proceeding and the Unapproved Drugs CPG,  December 14, 2011
  Politics, FDA, and the Plan B Decision,  December 13, 2011
  Pending DESI Program Proceedings - The List,  December 11, 2011
  FDA Proposes Generic Drug User Fee System and Performance Goals,  December 7, 2011
  FDA Proposes Biosimilar and Interchangeable Biological Product User Fee System and Performance Goals,  December 6, 2011
  FDA Proposes to Depart From Conventional Bioequivalence Metrics; Draft Guidance Proposes Partial AUC for Generic RITALIN LA,  November 30, 2011
  FDA Withdraws Avastin Breast Cancer Indication Approval,  November 22, 2011
  NJ District Court Dismisses Patent Use Code Counterclaim as Not Valid Under Current Law; All Eyes Move to the Supreme Court PRANDIN Use Code Case,  November 21, 2011
  FDA is Sued After Approving Generic Topical Corticosteroid Drug Products; Lawsuit Seeks Withdrawal or Suspension of ANDA Approvals,  November 16, 2011
  The FAIR Generics Act Makes its Debut; the Bill Takes a New Tack in Addressing Patent Settlement Agreements,  November 16, 2011
  Patent Settlement Agreements Remain in the Spotlight, But Not the Unified Spotlight the FTC Might Want,  November 15, 2011
  The Showdown Over AIA Section 37 Looms . . . . ,  November 14, 2011
  New Jersey District Court Says ANDA Approval Delay and Patent Uncertainty Are Insufficient to Support DJ Jurisdiction in Generic DETROL LA Litigation,  November 10, 2011
  Will the Hatch-Waxman Lock be Sprung in 2012?,  November 7, 2011
  FDA Prevails in 10th Circuit Unapproved Morphine Sulfate Case; Court Does Not Reach Merits of Grandfather Claim,  November 6, 2011
  Burr Amendment to Senate FDA Approps Bill Seeks FDA Approval Time Transparency,  November 2, 2011
  Executive Order Aims to Cure Drug Shortages,  November 2, 2011
  California Court of Appeal Affirms Superior Court Decision that CIPRO Patent Settlement Agreements Do Not Violate State Antitrust Laws,  November 1, 2011
  PTO Says PTE Not Available in "Reverse Photocure" Case,  October 31, 2011
  Betelgeuse, Betelgeuse, Betelgeuse! The ANDA "RLD Theory of Liability" Rears Its Ugly Head,  October 27, 2011
  FTC Issues FY 2011 Patent Settlement Report; Attempts to Keep Up the Heat on Passage of the Preserve Access to Affordable Generics Act,  October 25, 2011
  VIAGRA Patent Decision Gives Rise to Dispute Over ANDA Approval, Concern About 180-Day Exclusivity Forfeiture; Court Rigidly Applies Patent Statute,  October 24, 2011
  Sessions/Coburn Amendment to FDA Approps Bill Seeks To Effectively Nullify AIA Section 37 ANGIOMAX PTE Provision,  October 20, 2011
  FDA Proposes to Clarify and Update Orphan Drug Regulations,  October 19, 2011
  Regenerative Sciences Lawsuit Update and FDAs Attempt to Broaden the Definition of "Interstate Commerce",  October 17, 2011
  Office of Orphan Products Development SOPP Clarifies Orphan Drug Designation Policies,  October 16, 2011
  Lawsuit Seeks to Compel FDA Compliance with PDUFA User Fee Waiver Provisions,  October 13, 2011
  Landmark NORD Report on Orphan Drugs Authored By HP&M Director Shows FDA Flexibility in Approval,  October 11, 2011
  Lawyer, Physician, and Bioethicist Takes Over the Reins at FDA's Orphan Drug Shop,  October 6, 2011
  A Flurry of Generic Drug Labeling Carve-Out Citizen Petitions; Scorecard Updated,  October 3, 2011
  Rep. McCaul Seeks to Reinvigorate Interest in the Creating Hope Act of 2011; Introduces Companion Bill in the House,  September 29, 2011
  FDA Finalizes PDUFA User Fee Guidance,  September 27, 2011
  District Court Vacates 30-Month Stay Extension; Says Stay Only Applies to ANDAs Containing a Paragraph IV Certification,  September 27, 2011
  It Ain't Over 'Til It's Over ' The ANGIOMAX PTE Battle Takes Yet Another New Turn,  September 26, 2011
  GDUFA Negotiations Completed; Safety, Access, Transparency Are the Primary Aims of the New Program,  September 22, 2011
  FDA & OHRP Issue Draft Guidance on Exculpatory Language in Informed Consent,  September 19, 2011
  FDA Ramps Up Enforcement on Marketed Unapproved Human Drugs - Revised CPG Says New Products Will be Subject to Immediate Enforcement Action,  September 19, 2011
  Federal District Court in Florida Delivers a Decisive Blow to FDA's Authority to Regulate Pharmaceutical Compounding from Bulk Substances,  September 18, 2011
  New Citizen Petition Asks FDA to Require Homeopathic Drugs to be Tested for Effectiveness or Include a Disclaimer,  September 15, 2011
  USTR Embraces "TEAM" Approach in TPP Talks; Senators Back 12-Year Exclusivity for Biologics,  September 13, 2011
  HHS Issues Final Conflict of Interest Rules for PHS-Funded Research That Increases Burden to Institutions and Investigators,  September 11, 2011
  NORD Petition Requests FDA Policy Statement on Orphan Drug Review Flexibility,  September 8, 2011
  Last-Ditch Effort to Jettison "The Dog Ate My Homework Act" from the America Invents Act Fails,  September 8, 2011
  FDA Issues Proposed PDUFA V Performance Goals & Procedures,  September 7, 2011
  Citizen Petition Requests Rulemaking Process for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions,  September 6, 2011
  Nevada State Court Judge Says There's a Hole in Mensing Preemption for Some "Dear Doctor" Letters,  September 5, 2011
  FDA Issues Report to Congress on Findings and Recommendations of Rare and Neglected Tropical Disease Groups,  September 1, 2011
  FTC Issues Long-Awaited Final Report on Authorized Generics; Report Examines Both Short-Term Effects, Long-Term Impact on Competition & Drug Prices,  August 31, 2011
  FDA Issues Draft Guidance that Supports Developing a Risk-Based Approach to the Monitoring of Clinical Studies,  August 30, 2011
  Public Citizen Petitions FDA to Amend Generic Drug Labeling Regulations in the Wake of Mensing,  August 29, 2011
  Strength in Numbers? The Lobbying Push for a PTE,  August 21, 2011
  FDA Says Tenth Circuit Should Say Adieu to Grandfather Drug Case Without Much Ado; Not So Fast, Says Cody/Lannett,  August 15, 2011
  ANGIOMAX - The Other Patent Battle,  August 11, 2011
  FDA Denies ECR & Laser GRASE Petitions Following Voluntary Dismissal of Related Lawsuits,  August 10, 2011
  California Court Allows Case Against Homeopathic Drug Manufacturer to Proceed ,  August 9, 2011
  FDA Approval of Generic IMITREX STATdose Sheds Some Light on Auto-Injector "Sameness" Issues - But What About Other Combination Products?,  August 8, 2011
  Sturm und Drang: The TPP Agreement and Biologics Exclusivity,  August 7, 2011
  HHS Seeks to Enhance and Modernize Human Subjects Research Protections,  August 1, 2011
  PDUFA IV User Fees End With a Bang, Not a Whimper! Application Fee Increases by a Whopping 19.4% (or Almost $300K),  July 31, 2011
  District Court Says "Shall" Means "Must" in Challenge to PTO Denial of Interim Patent Term Extension,  July 25, 2011
  Will the Fourth Time be the Charm? FDA is Once Again Asked for Guidance on Drug Delivery Device Patent Orange Book Listing,  July 21, 2011
  The Scope of New Chemical Entity Exclusivity and FDA's "Umbrella" Exclusivity Policy,  July 20, 2011
  Court Dismisses, on Ripeness Grounds, Cephalon Challenge to Generic FENTORA Approval,  July 18, 2011
  The MDCO PTE Decision: In Play on Capitol Hill and in Action at the PTO,  July 14, 2011
  Priority Review Vouchers - Not Much Bang for the Buck,  July 11, 2011
  New Jersey District Court Denies Preliminary Injunction Motion in Generic CARBATROL Pre-MMA 180-Day Exclusivity Case; An Appeal Quickly Follows,  July 7, 2011
  Will the Dog Days of Summer Offer a Reprieve to FDA and the Regulated Industry (and Your Bleary-Eyed Bloggers)? Doubtful,  July 6, 2011
  Is Info in Paragraph IV Certification Notice Ltr Accompanied by Offer of Conf. Access Subject to Public Disclosure? One District Court has an Answer,  June 29, 2011
  Efforts to Obtain a PTE for ANGIOMAX Patent Continue as the U.S. House Passes an Amendment to the America Invents Act in "After Business Hours" Vote,  June 28, 2011
  DDMAC - When Two Well-Controlled Studies Do Not Equal Substantial Evidence,  June 27, 2011
  Pathway to Global Product Safety and Quality - FDA's Report Regarding Improving the Quality of Imports,  June 23, 2011
  Supreme Court Issues Decision on Generic Drug Preemption; To Borrow From Harry Caray - "Holy Cow! Generics Win! Generics Win!",  June 23, 2011
  Freedom and Unity to Use IMS Prescribing Data in Vermont,  June 23, 2011
  Tentatively, FDA Hones In On A Working Definition of Nanotechnology,  June 19, 2011
  Smarter than the Average Bear? Two Recent Lifecycle Management Strategies of Note,  June 13, 2011
  FDA Issues Final 505(q) Citizen Petition Guidance, Says Certification/Verification Statement Accuracy is Paramount,  June 9, 2011
  GAO Report Finds BPCA and PREA to be Ongoing Successes, But Says that FDA Needs to Improve Tracking of Products Studied for Pediatric Uses,  June 6, 2011
  FDA Denies Citizen Petition on Generic COMBIVIR 180-Day Exclusivity "First Applicant" Issue,  June 1, 2011
  FDA is Sued Over Generic CARBATROL; Lawsuit Challenges FDA Decisions on Pre-MMA 180-Day Exclusivity,  May 30, 2011
  A Flurry of Amicus Briefs Filed in the K-DUR Patent Settlement Appeal Seek a Reversal of a New Jersey District Court Decision,  May 23, 2011
  ISTA Sues FDA Over Generic XIBROM Approval, Says ANDA Approval Should Disappear in the Blink of An Eye,  May 17, 2011
  FTC Alleges Companies Were Asleep At the Wheel When They Failed to Report Settlement Agreements on AMBIEN CR,  May 15, 2011
  FDA Completes Implementation of Affordable Care Act Sec. 10609 "Generic Loophole" Provisions,  May 12, 2011
  FDA's Warning Letter "Close-Out" Process Is Not Working,  May 11, 2011
  D.C. District Court Grants FDA Motion for Summary Judgment in Spat Over Generic ALDARA Cream,  May 10, 2011
  FDA Gets the Ball Rolling on Biosimilar/Interchangeable Biological Product User Fee Program,  May 9, 2011
  The FTC's Latest Patent Settlement Report Will Serve as Fodder for the Commission's Crusade Against Patent Settlement Agreements,  May 8, 2011
  D.C. Circuit is Asked to Review Two DESI "New Drug" Decisions,  May 2, 2011
  NAD Case: Avoid Claim Confusion When Advertising Multiple Products,  April 28, 2011
  Academics Criticize the MMA's Failure-to-Market Forfeiture Provisions as Anemic Mechanism for Parked Exclusivity & MMA's DJ Provisions as Paper Tiger,  April 27, 2011
  Analyst Report Suggests Recent Uptick in NDA/BLA Refuse-to-File Letters Signals Changes at FDA,  April 26, 2011
  FDA Releases Opioid Class-Wide REMS,  April 21, 2011
  "Responding to America's Prescription Drug Abuse Crisis": Administration's New Action Plan Includes Changes to the CSA,  April 21, 2011
  Amendment to the America Invents Act Would Give MDCO Some Legislative Security in Battle Over ANGIOMAX PTE,  April 20, 2011
  ViroPharma's Preemptive Strike Over Generic VANCOCIN Fails; District Court Grants FDA's Motion to Dismiss,  April 19, 2011
  FDA Seeks to Expand Rules on Clinical Investigator Disqualification,  April 18, 2011
  FDA Reports to Congress on Generic Anti-Epileptic Drugs; Concludes Additional Study of Brand-Generic Switching is Needed to Better Understand Risks,  April 13, 2011
  Lawsuit Alleges False Marking Based on Orange Book "Advertising",  April 13, 2011
  Simultaneously Qualifying for and Forfeiting 180-Day Exclusivity Eligibility for Failure to Obtain Timely Tentative Approval,  April 12, 2011
  Georgia Department of Community Health Requires Showing of "Medical Necessity" for FDA-Approved Drug Over Compounded Versions,  April 7, 2011
  NJ District Court Punts in ASACOL DJ Action to Trigger 180-Day Exclusivity Forfeiture; Rules that Subsequent ANDA Applicant Lacks Standing,  April 5, 2011
  Decision in Lannett THALOMID Bioequivalence Study Sample Antitrust Lawsuit Could Reignite Debate on Generic Drug Availability and REMS Restrictions,  April 1, 2011
  Cost of Compliance - FDA's New Enforcement Discretion,  March 31, 2011
  Oral Argument in the Mensing-Demahy Generic Drug Labeling Preemption Case,  March 30, 2011
  Orange Book Patent Listing Precipitates DJ Action to Trigger Generic KEPPRA XR 180-Day Exclusivity Forfeiture,  March 28, 2011
  CMS Seeks Stakeholder Input on Implementation of Physician Payment Sunshine Law,  March 24, 2011
  Adverse Event Reports Might or Might Not be Material Information to Investors,  March 23, 2011
  FDA Issues New Guidance on PDUFA User Fee Waivers, Reductions, and Refunds; Guidance Represents the Culmination of 18 Years of FDA,  March 21, 2011
  Sen. Casey Takes Over the Reins for the Creating Hope Act; New Bill Substantially Mirrors Sen. Brownback's 2010 Version,  March 21, 2011
  Failure to Launch: OIG's Recommendations to HHS,  March 20, 2011
  Effective March 28, 2011 - New Safety Reporting Requirements for Certain Drug and Biological Products,  March 16, 2011
  Recent Hatch-Waxman Scholarship Suggests Patent Settlement & Product Hopping Create "Lethal Combination",  March 15, 2011
  Orange Book Patent Delisting Counterclaim Raised in 505(b)(2) Application Patent Infringement Litigation,  March 8, 2011
  Supreme Court Shuts Another Door on Patent Settlement Agreement Antitrust Challenge - Denies Certiorari in CIPRO Case,  March 7, 2011
  FDA Announces Major Enforcement Action on Marketed Unapproved Prescription Cough, Cold, and Allergy Drug Products,  March 2, 2011
  A Policy Shift: Medication Guides May be Eliminated From REMS in Some Cases,  March 1, 2011
  Letter Alleges Georgia Violated Controlled Substances Act by Importing Death Penalty Drug,  March 1, 2011
  Snowmageddon, a Government Shutdown, and Other Acts of Nature (Mother or Human)  What are the Effects on FDA Approval Decision Deadlines?,  March 1, 2011
  Fifth Circuit Vacates District Court "Second Inspection Ruling" in Compounding Pharmacy Case,  February 28, 2011
  The Itch is Scratched FDA Denies XYZAL Carve-Out Petition; Another Precedent Added to the Generic Drug Labeling Carve-Out Citizen Petition Scorecard,  February 24, 2011
  District Court's Extension of 30-Month Stay on Generic XYZAL Approval Ends; ANDA Sponsors Itching for FDA Decision on Carved-Out" Urticaria-Only Label,  February 23, 2011
  Legislation to Ban Authorized Generics During 180-Day Exclusivity Period Makes a Comeback in Congress,  February 21, 2011
  The President's FY 2012 Budget Would Create New User Fees, Ban Patent Settlements, and Reduce BPCIA Reference Product Exclusivity,  February 15, 2011
  Subsequent ANDA Sponsor Says DETROL LA Patent Has Gotta Go; But Would a Final Court Decision Trigger 180-Day Exclusivity?,  February 10, 2011
  Inmates Sue FDA Over Importation of Death Penalty Drug,  February 9, 2011
  The Fat Lady Goes Back to Her Dressing Room; Federal Circuit Denies MDCO Motions in ANGIOMAX PTE Litigation,  February 6, 2011
  OGD Finished 2010 on a High Note - Really High!,  February 3, 2011
  Orphan Drug Designations and Applications Took Off in 2010 While Orphan Drug Approvals Tapered Off,  January 31, 2011
  The Preserve Access to Affordable Generics Act Resurfaces Early in the 112th Congress,  January 30, 2011
  Another Week, Another Missive on BPCIA Exclusivity,  January 26, 2011
  Reports Detail FDA's 505(q) Citizen Petition Response Track Record; Section 505(q) May Have Some Unintended Consequences, FDA Says (Part I),  January 24, 2011
  Tussle over BPCIA "Market" Versus "Data" Exclusivity Continues; This Time the Generic Supporters Chime In,  January 21, 2011
  Regenerative Sciences - FDA Struggle Continues,  January 19, 2011
  NJ District Court Declines to Exercise Declaratory Judgment Jurisdiction in Feud Over Generic ANTARA; Lupin is Given Another Bite at the Apple,  January 19, 2011
  High Court Denies Apotex Petition on 180-Day Exclusivity,  January 18, 2011
  Apotex Seeks to Trigger 180-Day Exclusivity for Generic LEXAPRO Tablets,  January 17, 2011
  FDA Moves to Limit Maximum Dosage Strength of Acetaminophen in Prescription Combination Drug Products and Requires Labeling Changes,  January 13, 2011
  PTO Sued After Denying "Mildly Tardy" Second Interim PTE Request,  January 12, 2011
  Déjà vu! Senators Follow House Colleagues in Making BPCIA Exclusivity Clarifications; New Study Suggests Benefits of Longer Drug Exclusivity Period,  January 11, 2011
  32 State AGs Urge U.S. Supreme Court to Take on Patent Settlement Agreements,  January 10, 2011
  FDA Amends Informed Consent Regulations,  January 9, 2011
  FDA Seeks to Clean Up Unapproved Cough/Cold/Allergy Drug Market,  January 6, 2011
  BPCIA's Principal Authors Seek to Clarify Congressional Intent With Respect to 12-Year Exclusivity Period; PhRMA/BIO Request "Umbrella Exclusivity",  January 5, 2011
  Here We Go Again . . . . Amphastar Renews Generic LOVENOX Case Against FDA,  December 30, 2010
  U.S. Supreme Court Petitioned to Review Federal Circuit Patent Use Code Decision,  December 28, 2010
  Sandoz Requests 180-Day Exclusivity Forfeiture Decision for Generic HECTOROL,  December 21, 2010
  Court Upholds Exclusion of Former Purdue Executives,  December 20, 2010
  Provisions to Promote Approval of Rare and Neglected Disease Products Survive Chopping Block in the Senate's FY11 Omnibus Approps Bill,  December 15, 2010
  Sanofi Seeks Summary Judgment in Generic LOVENOX Dispute; Administrative Record Highlights Disagreements at FDA Over Generic Approval ,  December 14, 2010
  Apotex Cert Petition on 180-Day Exclusivity Forfeiture Decision is DOA, Says Teva in Opposition Brief,  December 13, 2010
  Bright "Orphan" Ideas Blossom,  December 10, 2010
  Supreme Court Will Review Generic Drug Preemption Cases,  December 10, 2010
  FDA Publishes Annual Guidance Agenda,  December 8, 2010
  Drug Purchasers Petition U.S. Supreme Court to Consider CIPRO Patent Settlement Case,  December 8, 2010
  The DEA Opines on a Pharmacist's "Corresponding Responsibility",  December 1, 2010
  Legal Setbacks and Legislative Inaction May Push the FTC to Consider "Plan C" to Address Patent Settlement Agreements,  November 29, 2010
  Sandoz Attempts to Clear Up Post-Losartan "Bottleneck" with DJ Action on Disclaimed Patent,  November 22, 2010
  FDA Says There is No Scientific Evidence of Problems in Switching Bioequivalent Anti-epileptic Meds, But Further Study is Warranted,  November 21, 2010
  District Court Grants FDA Motion to Dismiss in Unapproved Morphine Sulfate Litigation,  November 17, 2010
  Generic Drug Industry Headed for a "180-Day Exclusivity Cliff",  November 16, 2010
  FDA Files Amicus Brief on Generic Drug Preemption,  November 16, 2010
  Yet Another Import Issue Resolved by Filing a Lawsuit,  November 15, 2010
  Applicant Claims PTE Eligibility Based on PhotoCure Dicta; A Set-up to a Court Challenge?,  November 14, 2010
  PTO Clarifies PTE Availability in Post-PhotoCure and Post-Ortho-McNeil World; PhotoCure Takes Advantage of . . . . PhotoCure,  November 10, 2010
  Senator Cites Ethical "Defect" in Biosimilars Law Exclusivity Provisions; Proposes Legislative Fix,  November 4, 2010
  FDA Issues Draft Guidance on the Qualification of Drug Development Tools,  November 2, 2010
  Solicitor General Files Amicus Brief in Mensing Cases on Generic Drug Preemption; Recommends that the Supreme Court Deny Review,  November 2, 2010
  GAO Report Blasts FDA for Failure to Implement 2008 Recommendations,  October 31, 2010
  Amphastar Challenges FDA Import Detention,  October 26, 2010
  Improving Access to Clinical Trials Act Becomes Law,  October 19, 2010
  Generic LIPITOR - the Brass Ring of All Brass Rings for 180-Day Exclusivity; How Will Exclusivity Resolve?,  October 12, 2010
  Another Push to Legislatively Overturn Forest Group False Marking Decision,  October 11, 2010
  IOM Issues Report on Rare Diseases and Orphan Products; Recommends an Integrated National Strategy,  October 7, 2010
  Does Subsequent Paragraph IV Filer Have Legally Cognizable Interest in When 1st Filer's 180-Day Exclusivity Period Begins for DJ Jurisdiction Purposes,  October 6, 2010
  WSJ Stakes Out Position on Patent Settlements; Takes Issue with the FTC's "Evangelical Zeal",  October 5, 2010
  It Lives!! Apotex Asks the Supreme Court to Review Generic COZAAR/HYZAAR 180-Day Exclusivity Decision,  October 5, 2010
  California's Green Chemistry Regulations; A Lot of R&R (Requirements and Responsibilities) for Regulated Industry,  September 28, 2010
  Flare-Up Over Generic Herpes Drug Could be Short-Lived ,  September 27, 2010
  Novartis Sues FDA Over Generic FAMVIR; Alleges that FDA Failed to Require a Split Certification,  September 23, 2010
  Senators Vigorously Object to the Inclusion of Patent Settlement Provisions in FY 2011 Appropriations Bill,  September 21, 2010
  A High Wire Balancing Act: FDA and CMS to Consider Parallel Review of Medical Products,  September 21, 2010
  FDA Set to Announce Public Hearing on BPCI Act Implementation,  September 20, 2010
  OGD Has Put the Brakes on ANDA Supplement Reviews; Will it Help Push Generic Drug User Fees Along?,  September 16, 2010
  Put it on Mr. Underhill's Bill! FDA Sets Priority Review Voucer Redemption Fee at Almost $4.6 Million,  September 14, 2010
  ViroPharma Sues FDA Over Generic VANCOCIN; Alleges that FDA Violated the APA in Effectively Amending Bioequivalence Regulations,  September 13, 2010
  Psych! Second Circuit Denies Rehearing Petition in CIPRO Patent Settlement Litigation after Panel Invites Petition,  September 9, 2010
  All Eyes are on APP's Intervention Motion as the Government Bows Out of ANGIOMAX PTE Litigation,  September 9, 2010
  U.S. Supreme Court to Rule on When is an AER material Information that Must be Disclosed to Investors,  September 8, 2010
  Report Predicts Tough Road Ahead for Some Generics After Federal Circuit Patent Use Code Decisions,  September 3, 2010
  APP Moves Forward With Appeal Notice in ANGIOMAX PTE Litigation in Light of PTO/FDA Indecision,  September 2, 2010
  District Court Denies Apotex Declaratory Judgment Motion on Generic ARICEPT; Does Not Accept Prompt Launch" & "Indefinite Delay" Jurisdiction Theories,  September 1, 2010
  Allergan Settles with DOJ Related to the Sales and Marketing of BOTOX,  September 1, 2010
  HHS Seeks Input on Potential Benefits and Risks of Synthetic Biology,  August 31, 2010
  GAO Issues Report on Non-Inferiority Studies; Finds No Evidence of "Biocreep," But More Conservative Use of Such Studies to Support Approval,  August 30, 2010
  Patent Expiration, Pediatric Exclusivity, and Generic Drug Approval - Some Interesting Tensions Between the FDC Act and Patent Law,  August 18, 2010
  New Analysis Takes Issue with CBO Patent Settlement Legislation Cost Estimate,  August 16, 2010
  FDA Issues NOOH Proposing to Withdraw All Midodrine HCl Approvals,  August 16, 2010
  Regenerative Sciences Faced with FDA Injunction,  August 11, 2010
  180-Day Exclusivity - From Abacavir Sulfate to Zolpidem Tartrate ,  August 10, 2010
  Senator Brownback Introduces Creating Hope Act of 2010;Would Change Priority Review Voucher Program;Extend to Applications for Rare Pediatric Diseases,  August 5, 2010
  UPDATE - Generic Drug Labeling Carve-Out Citizen Petition Scorecard,  August 4, 2010
  Up, Up and Away! FDA Sets Fiscal Year 2011 User Fee Rates,  August 3, 2010
  MDCO Prevails in ANGIOMAX PTE Case - District Court Grants Summary Judgment; Will the PTO Appeal?,  August 3, 2010
  Preserve Access to Affordable Generics Act Included in FY 2011 Financial Services and General Government Appropriations Bill,  July 30, 2010
  Federal Circuit Denies Rehearing Petition in PRANDIN Patent Use Code Case; Dissents Argue that "Section viii" Carve-Outs Eviscerated,  June 29, 2010
  DC District Court Denies Sanofi Summary Judgment Motion in Generic ELOXATIN Case; Refuses to Reinstate 30-Month Stay on ANDA Approvals,  July 28, 2010
  The Other Shoe Drops . . . . Sanofi Sues FDA Over Generic LOVENOX Approval,  July 27, 2010
  District Court Denies Motion for Temporary Restraining Order and Preliminary Injunction in Marketed Unapproved Morphine Sulfate Oral Solution Case,  July 26, 2010
  FDA Takes Action on LOVENOX Citizen Petition and Approves Sandoz ANDA,  July 23, 2010
  Federal Circuit Denies Rehearing Petition in LEVAQUIN Patent Term Extension Case,  July 19, 2010
  Senate FY 2011 FDA Appropriations Bill Should be Another Big Step Forward for Rare and Neglected Disease Patients and Advocates,  July 16, 2010
  Graceway Sues FDA Over Generic ALDARA Cream Decisions; Alleges that Petition Response is Contrary to Basic Science, Common Sense, and Precedent,  July 13, 2010
  Analysis Shows Patent Use Codes Have Doubled Since August 2003,  July 8, 2010
  D.C. Circuit Affirms District Court Ruling Concerning Losartan 180-Day Exclusivity Forfeiture Issue,  July 6, 2010
  Coalition for Mercury-Free Drugs Fails to Prove Standing in Thimerosal Case,  July 5, 2010
  NORD Chair/HPM Director Presents Opening Testimony at First Ever FDA Orphan Drug Hearing,  June 30, 2010
  Regenerative Sciences, Inc. Attempts to Avoid FDA Action,  June 27, 2010
  OIG Issues Recommendations to FDA to Improve its Oversight of Foreign Clinical Trial Data,  June 25, 2010
  Pfizer Withdraws Subpart H Drug MYLOTARG From the Market,  June 22, 2010
  Senator Nelson Takes Another Crack at the Drug Price Competition Act,  June 16, 2010
  Relinquishment and Waiver of 180-Day Exclusivity Post-MMA; What is FDA Precedent and Where Might FDA be Headed?,  June 14, 2010
  "Preserve Access to Affordable Generics Act" Resurfaces in Senate; Patent Settlement Litigation Front Heats Up,  June 10, 2010
  A New 180-Day Exclusivity Punt - But Don't Read Too Much Into It,  June 7, 2010
  Is Another Challenge to the PTO's PTE "Product" Interpretation Looming?,  June 3, 2010
  Pennsylvania District Court Decision Signals a New Turn in the Generic Drug Preemption Debate; A Tough Pill to Swallow for the Generic Industry,  June 2, 2010
  FDA Denies Citizen Petition on Animal Testing,  June 1, 2010
  Sen. Kerry Introduces ANGIOMAX PTE Amendment to Tax Extenders Act of 2009,  May 27, 2010
  U.S. Supreme Court Invites Solicitor General to Express the Views of the United States in Generic Drug Preemption Cases,  May 25, 2010
  Court Orders and PTO Grants Second Interim PTE for ANGIOMAX,  May 24, 2010
  FDA's Regulation of Nanotech: a Change in the Wind?,  May 19, 2010
  Losartan - D.C. Circuit Denies FDA's Petition for Panel Rehearing and Rehearing en banc; Roxane/Apotex Case Continues,  May 18, 2010
  Advocacy Groups Ask FDA to Further Crack Down on Marketed Unapproved Drugs,  April 20, 2010
  FDA Rules Against Patent Expiration 180-Day Exclusivity Forfeiture for Generic COZAAR/HYZAAR, But in Doing So FDA Repudiates Its Own Decision and Asks,  March 29, 2010
  Here We Go Again! MDCO Launches Another Lawsuit Against the PTO Over ANGIOMAX PTE,  March 26, 2010
  Health Care Reform Becomes Law - HP&M Issues Summary of Drug and Device Provisions ,  March 24, 2010
  PTO Once Again Denies PTE for ANGIOMAX Patent . . . But Not Before Issuing an Interim Extension; MDCO is Outraged,  March 22, 2010
  Court Orders and Declares that Teva Has Not Forfeited 180-Day Exclusivity for generic COZAAR/HYZAAR,  March 17, 2010
  PTO's ANGIOMAX PTE Denial is Vacated and the Case Goes Back to PTO - What Happens in the Interim?,  March 17, 2010
  FDA Grants Petition on Pioglitazone Split Certification Issue; It's Caveat Utilitor on Old Orange Book Patent Listings,  March 16, 2010
  Rep. Hinchey Introduces the FDA Improvement Act of 2010; the Bill Would Unravel User Fee Legislation, Among Other Changes,  March 15, 2010
  The Last Shall Be First . . . . The Case of Generic FLOMAX,  March 10, 2010
  FDA Rules Against Forfeiture for Generic ALDARA Cream,  March 9, 2010
  District Court Dismisses Wyeth Lanham Act Case Concerning Generic PROTONIX, But Leaves the Door Open for Further Litigation,  March 8, 2010
  Rep. Watson Introduces the Compassionate Access Act of 2010,  March 3, 2010
  Teva Prevails in Generic COZAAR/HYZAAR 180-Day Exclusivity Forfeiture Litigation; the Decision is a Game-Changer,  March 2, 2010
  PTO Denies PTE for ADVAIR DISKUS Patent; Again Clarifies that PTEs Not Available for "Synergistic Combinations" Containing Previously Approved Drugs,  March 2, 2010
  FDA Issues Two New Clinical Trial Design Guidances,  March 1, 2010
  OGD's ANDA Backlog and Median ANDA Approval Times are Up - WAY UP! "The Solution Lies in Resources," Says FDA Commissioner Hamburg,  February 25, 2010
  President's Working Proposal for Health Care Summit Contains Familiar Drug and Device Provisions,  February 22, 2010
  Proposed Rule Requires Sponsors to Report Suspected Falsification of Data to FDA,  February 19, 2010
  FDA Announces a New Class-Wide REMS,  February 18, 2010
  TRICARE Involves Public in its Reconsideration of Retail Pharmacy Refund Program,  February 10, 2010
  Recent Rulings Once Again Shine the Light on Sham Citizen Petition Antitrust Issues,  February 9, 2010
  Has FDA Already Resolved One Critical Issue Concerning Forced Rx-to-OTC Switches?,  February 8, 2010
  Stipulation of Dismissal in Winston Laboratories Small Business User Fee Waiver Case,  February 3, 2010
  All for One and One for All - FDA Denies Graceway Petition on Generic ALDARA Cream,  February 3, 2010
  Requests for Orphan Drug Designation Explode in 2009; But Designation Success Rate is Low,  February 2, 2010
  The Medicines Company Tosses Up a Hail Mary Pass - Sues PTO and FDA Over ANGIOMAX Patent Term Extension Decisions,  February 1, 2010
  FDA Denies Petition on "Original NDA" Patent Certification Issue,  January 28, 2010
  Taking Stock of FDA's 180-Day Exclusivity Forfeiture Decisions - A Forfeiture Scorecard,  January 26, 2010
  Senators Pryor and Cardin introduce the Nanotechnology Safety Act of 2010,  January 24, 2010
  2009 - Another Banner Year for Orphan Drug Designations,  January 21, 2010
  Down and Out in MA - The PTO Denies The Medicines Company's Request for Reconsideration for ANGIOMAX Patent Term Extension,  January 20, 2010
  New Draft Guidance Document on Institutional Review Board (IRB) Continuing Review,  January 18, 2010
  FTC Releases Analysis of Pay-for-Delay Settlements; Renews Call for Legislation,  January 13, 2010
  Inclusion of Pay-for-Delay Ban in Health Care Bill Urged; FTC to Hold Press Conference Announcing Pay-for-Delay Analysis,  January 12, 2010
  WLF Urges Supreme Court Review of Ortho Biotech Decision; Argues False Claims Act is Intended to Combat Fraud, not Legitimate Product Promotion,  January 11, 2010
  Kaiser Permanente Submits Citizen Petition on REMS,  January 8, 2010
  FDA Issues Exclusivity Decision for EMEND; Agency Reverses Course and Grants NCE Exclusivity,  January 5, 2010
  Tufts Report Concludes that Product Approvals for Neglected Diseases are on the Rise,  January 3, 2010
  Trends in FDA's Use of Class-Wide REMS  December 2009
  Efforts to Combat Prescription Drug Abuse Should Not Limit Access to Compounded Pain Medicine  September 2009
  Dermatologic Therapy  May 9, 2009
  Hyman, Phelps & McNamara Issues Analysis Discussing the Implications of the Supreme Court's Wyeth v. Levine Decision  March 16, 2009
  Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing  January 2009
  A Bad Fit: Qui Tam Actions and Off-Label Use Allegations  November 2008
  Surprise!...That Food Is Now a Drug  October 2008
  Personalized Medicine - Panacea or Pipedream?  September 2008
  Checking the Box Can Get You in the Hot Seat  August 2008
  Regulatory Pathways for Molecular Dx - Detailing the Various Options Available and What Each Requires  August 1, 2008
  PhRMA Releases Revised "Code on Interactions with Healthcare Professionals" More Restrictive than July 2002 Version; HPM Issues Summary Memorandum  July 10, 2008
  Primer on Regulation of Diagnostic Assays - Essential Points that Pharmaceutical Companies Need to Know Right Now  July 1, 2008
  Preemption of State Law Tort Suits against Medical Device and Drug Manufacturers  June 2008
  FDA's Regulatory Extensions: An Overburdened Agency Assigns Itself New Responsibilities  June 13, 2008
  As Nanotech Goes to Market, What Lessons Can We Draw From Biotech?  April 2008
  FDA Regulation of Nanotechnology: What Are the Rules of the Road?  February 2008
  Court case determines specimen ownership  January 2008
  Clinical Trial Participation Unaffected by Disclosure of Investigator's Financial Stake  December 18, 2007
  FDA's Regulatory Scheme for Human Tissue  November/December 2007
  FDA Amendments Act - HPM Issues Detailed Summary and Analysis  October 2007
  The OxyContin Case - Something for Everyone  September 2007
  CMS Final Rule on the Drug Rebate Program  August 9, 2007
  BioShield II: A Step in the Right Direction?  July 2007
  CMS Issues Draft of Revised Clinical Trial Policy, Renamed Clinical Research Policy  April 11, 2007
  Are Food and Drug Lawyers 'Real' Lawyers?  April 2007
  Abigail Alliance v. von Eschenbach  March 2, 2007
  Medicare Coverage with Evidence Development and Potential Impact on Your Clinical Trial Policy  January 30, 2007
  FDA Announces Proposed Regulations to Overhaul and Expand the Availability of Experimental Drugs and to Clarify Permissible Charges to Patients  December 12, 2006
  State of the Union: Drug-Device Combinations  November 2006
  Pharmaceutical Law R&D 101: Legal Issues During Research and Development  October 4, 2006
  Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics Bill  September 29, 2006
  CMS Proposed Changes to ASP Calculation Methodology  August 2006
  FDA's Final Compliance Policy Guide for Marketed Unapproved Drugs ─ Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?  August 11, 2006
  CMS Coverage with Evidence Development Policy Highlights Differences Between FDA and CMS Clinical Evidence Requirements  July 12, 2006
  Medicare to Reconsider Clinical Trial Policy  July 10, 2006
  New Law Reins in "Authorized Generics" Despite Generic Industry Court Losses, But Leaves Several Ambiguities  June 2006
  Sponsor of Clinical Drug Trial Not Required to Continue Providing Drug to Participants After Termination of the Study  May 2006
  District Court Rules on Simvastatin 180-Day Exclusivity  May 5, 2006
  Federal Court Holds FDA to 180-day Statutory Deadline for Approving Drug Marketing Applications  April 10, 2006
  Product liability drug case not preempted by FDC Act  March 3, 2006
  Bioshield II: One Step Forward, One Step Back?  March/April 2006
  Medicare CED: Considerations and Implications  March/April 2006
  FDA Issues Long-Awaited Prescription Drug Labeling Regulations  January 26, 2006
  Clinical Trials Disclosure Requirements: Too Much of a Good Thing?  January 2006
  FDA's Unauthorized User Fee Money Grab  August 12, 2005
  Just Sign on the Dotted Line?  June 20, 2005
  Federal and State Requirements for HCT/Ps: An Overview  May 2005
  FDA Draft Guidance on Exploratory IND Studies  April 22, 2005
  FDA Issues Good Review Management Principles and Practices Guidance Document  April 22, 2005
  FDA Must Reform Its Arbitrary Drug Name Review Process  January 28, 2005
  Current Good Manufacturing Practices, and FDA Enforcement Actions and Inspections  July 2004
  Vermont AWP Disclosure and Drug Marketer Gift Reporting Laws  June 2004
  State Regulation of Pharmaceutical Clinical Trials  2004
  U.S. Food and Drug Law and FDA - A Historical Background  July 2002
  First Amendment Implications of Labeling and Advertising Restrictions  June 22, 2002
  How FDA's New Labeling Rule Could Preempt State Law
  Comments, Pediatric Testing of Prescription Drugs: The Food and Drug Administration's Carrot and Stick for the Pharmaceutical Industry
  It's the Law: Compliance with FDA's Financial Disclosure Rule  November 1999
  The History, Provisions and Implementation of the Generic Drug Enforcement Act of 1992  1994
  FDA Announces Establishment of a Public Docket to Receive General Public Comments on Compounding,