Expertise in all things FDA
Jeff Gibbs is a panel member for the session on “Hot Topics in Medical Device Regulation: 510(k) Process; Risk Management; Social Media” at the FDLI Medical Device Regulation and Litigation Conference. The Madison Hotel Washington, DC
Ricardo Carvajal is participating in a panel on “The Impact of the Food Safety Modernization Act on the Food Industry” at the ABA Section of Litigation Food & Supplements Second Annual Workshop. Sara Lee Corporation 3500 Lacey Rd Downers Grove, IL
Anne Marie Murphy speaking on “FDA Draft Guidance on Risk-Based Monitoring of Clinical Trials” at the Clinical Trial Oversight Summit. Omni Parker House Boston 60 School Street Boston, MA
Jeff Shapiro is participating in the :”Interactive Session: How to Respond to 483s and Warning Letters” at the AdvaMed Medical Device Workshop on FDA Inspections, Warning Letters & CAPA. Sheraton Crystal City Crystal City, VA
In recent years, both industry and consumer groups have grown frustrated with the 510(k) notification process, the most common premarket review process for medical devices. In 2009, in response to these concerns, the Center for Devices and Radiological Health (CDRH) began an internal review of …
Kurt Karst is speaking on “To 505(b)(2) or Not To 505(b)(2) Jumping the Legal Hurdles for Inhaled Drug Products” at the Respiratory Drug Delivery conference. JW Marriott Desert Ridge Resort & Spa Phoenix, Arizona
Bob Dormer will be moderating the session on “Best Practices in Dealing with FDA Inspections: Before, During & After” at the Florida Medical Device Symposium. Hilton St. Petersburg Carillon Park St. Petersburg, FL
Dave Clissold is moderating the session on “Building a Comprehensive Nicotine Regulatory Policy” at FDLI’s 55th Annual Conference. The Ronald Reagan Building and International Trade Center 1300 Pennsylvania Avenue, Washington, DC
Jeff Shapiro is speaking as part of the FDA Center Director’s Roundtable panel at the FDLI’s 55th Annual Conference. The Ronald Reagan Building and International Trade Center 1300 Pennsylvania Avenue, NW Washington, DC
Jeff Gibbs will be speaking on “Advertising and Promoting In Vitro Diagnostics” at the Association of Medical Diagnostics Manufacturers Annual Meeting. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road North Bethesda, MD
Anne Marie Murphy is speaking on “FDA Draft Guidance on the Movement toward a Risk-Based Approach” at CBI’s Risk-Based Approaches to Clinical Investigations. Philadelphia, Pennsylvania
Kurt Karst will be conducting the Thompson Interactive Webinar on “PDUFA V: Preparations for the New Fees and Performance Goals” 2:00 pm ET/1:00 pm CT/12:00 pm MT/11:00 am PT Duration: 90 minutes
Nutritional Outlook – The manufacturer’s resource for dietary supplements & healthy foods and beverages. Additional information available here.
12:30 to 2:00 p.m. ET Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes. The appeal processes in both CDER and CDRH offer numerous strategic and procedural …
Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes. The appeal processes in both CDER and CDRH offer numerous strategic and procedural advantages that, when used …
Kurt Karst is speaking on “Hatch-Waxman and BPCIA Overview” at ACI’s FDA Boot Camp. Doubletree Suites Times Square New York, NY
Jennifer Newberger will be speaking on “Clinical Investigations” at FDLI’s Introduction to Medical Device Law and Regulation conference. Park Hyatt Washington Washington, DC
Jeff Shapiro will be speaking on “Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)s” and on “Advertising & Labeling” at the RAPS Medical Device Submission & Compliance Strategies for the US Market workshop. RAPS Training Facility Rockville, MD
Kurt Karst will be speaking on “Legal Considerations to Establish Biosimilarity and Therapeutic Interchangeability” at the University of Texas College of Pharmacy International Conference on Drug Development. He will also be participating in Roundtable Discussion. Austin, TX
Paul Hyman will be presenting “Regulatory, Legal and Political Processes in the Development of Food Labeling” at the National Kidney Foundation – The Public Health Impact of Phosphorus Homeostasis in Early CKD conference. Florida
John Gilbert will moderate the session on “The Scheduling Process: What You Need to Know” at the FDLI Controlled Substance Regulation conference. Hogan Lovells Washington, DC
Ricardo Carvajal is a moderator for the Labeling and Advertising session at FDLI’s Food Week conference. Park Hyatt Washington 24th & M Streets Washington, DC
On December 27, 2011, the Center for Devices and Radiological Health (CDRH) issued a draft guidance document on its appeals processes. While the guidance document is helpful in explaining the appeals processes, it does not go far enough. Even if the draft guidance is finalized, …
In the December 19, 2011 Federal Register, CMS published a long-awaited proposed regulation to implement the transparency report requirements of the Patient Protection and Affordable Care Act. Hyman, Phelps & McNamara, P.C. has prepared a summary of the proposed rule. The CMS proposal is unusual …
Bob Dormer will be speaking on “Critical Issues Related to Regulation of Follow-on Biologics” at the University of Maryland, School of Pharmacy, Center on Drugs and Public Policy Invitational Conference.
Jeff Gibbs will be participating in the “Hands on Interactive Session: How to Respond to 483s and Warning Letter” at the AdvaMed conference on Avoiding A Warning Letter. Marriott Metro Center Washington, DC
Jeff Shaprio is speaking on “The Evolution of Expectations Over Time” at the AdvaMed conference: Avoiding A Warning Letter. Marriott Metro Center Washington, DC
John Fleder will be a panel member for the “Hot Topics in Criminal Litigation and Investigative Enforcement: 2011 Review, 2012 Preview” discussion at the FDLI Enforcement, Litigation and Compliance Conference. The Westin Washington, DC
On December 2, 2011, Hyman, Phelps, & McNamara filed comments (here and here) to the controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued in July 2011. The current draft guidance ignores the balance struck by the Dietary Supplement Health and Education Act …
Jeff Gibbs is speaking on “Understanding the Potential Impact of Changes to the FDA 510(k) System” at R&D Portfolio Management for Medical Devices conference. San Diego, CA
Ricardo Carvajal is speaking on “Navigating Today’s Labeling Requirements&And What’s Coming Up” at the IFT Food Policy Impact conference. Sheraton Crystal City Washington D.C.
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Of Counsel, and former diversion investigator for the Drug Enforcement Administration (“DEA”), Larry K. Houck, explains the scope of DEA pre-registration and cyclic inspections as a step-by-step guide to actions and procedures …
Ricardo Carvajal is the co-instructor for IFT food labeling short course: Labeling Requirements and Implications for Foods Marketed in the U.S. Sheraton Crystal City Washington D.C.
Josephine Torrente is speaking at the Regulatory Issues For IP Professionals conference in the sessions: – Orphan Exclusivity – Regulatory Strategy and Appropriate Interaction with Authorities – The Regulatory Frameworks for Advanced Therapy Medicinal Products Harrington Hall Hotel, London
Jeff Gibbs is speaking on “Prepare your Clinical Trials for Compliance with New FDA Regulations on LDTs and IVDs” at Biomarker Applications For Improved Clinical Trial Outcomes. Hilton Boston Back Bay 40 Dalton Street Boston, MA
Diane McColl will be presenting “Routes to U.S. Market for Functional Ingredients in Foods, Medical Foods, and Dietary Supplements” at the Conference of the American College of Nutrition. Malcolm Forbes Conference Center of Morristown Memorial Morristown, NJ
Kurt Karst is conducting the Thompson Webinar “Navigating the Orphan Drug Designation Process: Benefits of Obtaining Designation”. 2:00 pm ET/1:00 pm CT/12:00 pm MT/11:00 am PT Duration: 90 minutes
Jeff Shapiro is speaking on “Recent Update of Compliance Issues” at the AdvaMed Advertising and Promotion of Medical Devices in an Age of DTC and Social Media Marketing conference. Four Points Sheraton Downtown Washington, DC
Josephine Torrente will be speaking on “Reading the Drug Safety Tea Leaves – Top Legal and Compliance Challenges that Lie Ahead” at the Fourth Annual Risk Management and Drug Safety Summit. National Press Club Washington, DC
Kurt Karst will be conducting the FDA News webinar “Marketed Unapproved Drugs”. 1:30 to 3 pm EST
Jeff Gibbs will be speaking on “The Basics: Understanding and Working with the FDA – Jurisdiction, Functions, Organization, and Operations” at the ACI’s FDA Boot Camp Device Edition conference. Sutton Place Hotel Chicago, IL
Diane McColl will be speaking on “The FDA Food Safety Modernization Act And What It Means For Importers” at the European Food Law Association Food Law Conference. Brussels, Belgium
Kurt Karst is speaking on “Generics in the US: A Regulatory Primer on Filing and Recent Actions” and in the Workshop on “Pay-to-Delay Agreements” at the RAPS Regulatory Convergence Conference. Indiana Convention Center Indianapolis, IN
Jeff Shapiro will be conducting the Thompson webinar: Combination Products – Classification, Regulations, and Guidances 2:00 pm ET/1:00 pm CT/12:00 pm MT/11:00 am PT Duration: 90 minutes
Josephine Torrente is a panel moderator for “Collaborating on an Agenda for the Future – A Dialogue to Address the Challenges in Orphan Product Development” at the National Organization for Rare Disorders (NORD) US Conference on Rare Diseases and Orphan Products. Washington, DC
Kurt Karst will be speaking at the Informa Inhalation Drug Development Conference London, UK
Frank Sasinowski is a panel member for “The Special Importance of Patient-Academic-Industry-Government Collaboration in Orphan Product Development” at the DIA & National Organization for Rare Disorders (NORD) US Conference on Rare Diseases and Orphan Products. Washington, DC
Kurt Karst will be presenting “REMS Studies and Generic Entry: Exploring the Latest Regulatory Conundrum Affecting Pharmaceutical Patent Life Cycle Strategies” at ACI’s 12th Annual Maximizing Pharmaceutical Patent Life Cycles conference. New York, NY