Expertise in all things FDA
Alan Kirschenbaum is speaking on “Analyzing CMs/FDA Interplay in Government Payor Pricing and Reimbursement: Interpreting the Intent Behind the Inclusion of FDA Regulatory terminology in the AMP Draft Rule and understanding Its Repercussions” at the ACI Prescription Drug Pricing conference. Doubletree Suites Times Square New York, …
Doug Farquhar is a co-panelist for the session on “Regulation of Pharmacy Compounding: Historical Analysis” at FDLI Pharmacy Compounding Webinar. 8:30 a.m. to 1:30 p.m EST Hyman, Phelps & McNamara Office 700 13th Street, NW Suite 1200 Washington, DC
On February 8, 2013, CMS published its final regulation implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act. Hyman, Phelps & McNamara has prepared a memorandum summarizing the final rule.
Dave Clissold speaking on: Orphan Exclusivity . . . continued Regulatory Strategy and Appropriate Interaction with Authorities The Regulatory Frameworks for Advanced Therapy Medicinal Products at the EU and US Regulatory Issues for IP Professionals conference. Geneva
12:00 – 2:00 p.m. ET Register This webinar is not just another summary of the long-awaited decision by the Second Circuit in United States v. Caronia, available here. Nor is it merely high-level positing about the future of off-label promotion prosecutions, such as here and here. …
Anne Walsh is speaking on “Freedom to make Truthful Promotional Speech: Rediscovering First Amendment Protection Strategies for your Marketing Defense” at the ACI conference on Advertising, Promotions and Digital Marketing for the Life Sciences Industry. Union League Philadelphia, PA
Jeff Gibbs presenting a “Medical Device Legal Update” at the New York State Bar Association Annual Meeting of the Food, Drug and Cosmetic Law Section. Hilton 1335 Avenue of the Americas New York, NY
Kurt Karst will be speaking on “Patent and Non-Patent Exclusivities for Drug and Biological Products in the USA – An Overview and Current Developments” at the Global IP Convention. INDIA
Jeff Shapiro conducting audioconference on “When a 510(k) or PMA Goes Off Track – FDA’s Appeals Process”. 11:30 am to 12:30 pm EST
The increase in prescription drug abuse in the United States is the result of multiple factors (e.g.,rogue Internet pharmacies, pain clinics, and doctor shopping) often requiring law enforcement and the regulated industry to play catch-up to address the ever-changing sources of diversion. However, the bulk …
Diane B. McColl has been elected to serve as the new President of the International Society of Regulatory Toxicology and Pharmacology (“ISRTP”).
John Fleder is moderating the session “Hot Topics in Enforcement: 2012 Review, 2013 Preview” at the FDLI Enforcement, Litigation and Compliance Conference FDLI Conference. The Westin Georgetown Washington, DC
Ricardo Carvajal is speaking on “Food Import and FSMA Preventive Controls” at Food Chemical News’ The Impact of FSMA on Food Importing Conference. Washington, DC
Kurt Karst is speaking at the Workshop: “Hatch-Waxman and BPCIA 101 – A Primer on IP Basics and Regulatory Fundamentals” at ACI’s Paragraph IV Disputes conference. San Francisco, CA
Josephine Torrente speaking on “Innovators, Generics, and REMS: Current and Emerging Issues” at the Risk Management and Drug Safety Summit. The National Press Club 529 14th Street, NW Washington, DC
Dave Clissold is speaking at the “EU and US Regulatory Issues for IP Professionals” on “Orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products”. The Rembrandt Hotel London, England
Bob Dormer is a panelist for the session on “Pre-Conference Intensive Deep-Dive into the Orphan Drug Act: Demystifying the Designation Process and Discovering the Accompanying Incentives” at the ACI Orphan Drugs and Rare Diseases Conference Hyatt Regency Boston, MA
Frank Sasinowski will take part in Catholic Medical Mission Board (CMMB) meetings at the Vatican, including with the Pope, addressing the medical and pharmaceutical needs of people around the world. During the past 10 years, CMMB has delivered over $2 billion of medicines in …
Katie Bond is presenting “Doing Business in High-Risk Categories” at the Council for Responsible Nutrition/VIRGO Health & Nutrition.
Bob Dormer is speaking on “Hatch-Waxman Basics: Abbreviated Applications, Patents and Exclusivities” at the FDLI Introduction to Drug Law and Regulation conference. Hilton East Brunswick Hotel New Brunswick, NJ
Frank Sasinowki is lecturing at Cornell University’s Sloan Program in Health Administration on “Drug Development and Health Care”. Ithaca, NY
Jeff Shapiro is speaking on “Review of Recent Compliance Issues” at the AdvaMed/MTLI Advertising and Promotion Workshop. Washington Marriott Metro Center Hotel Washington, DC
Frank Sasinowki, board member of the National Organization for Rare Disorders (“NORD”), is giving the keynote address for the Campaign Urging Research for Eosinophilic Disease’s (“CURED’s”) first research symposium on eosinophilic gastrointestinal disorders (“EGID”).
Jeff Gibbs is a Tutorial Instructor for “Personalized Medicine” session Panelist for “Regulatory, Ethical and Social Policy Issues in Personalized Medicine: Discovery to Clinic” session Panelist for “Regulatory Pitfalls in Getting IVDs and Companion Diagnostics FDA Approved Communications with the FDA” session at DIAs 7th Annual Conference Discovery through …
For the third year in a row, Hyman, Phelps & McNamara, P.C. has been ranked as a “Tier 1” law firm in the area of “FDA Law” by the folks over at U.S. News & World Report, who once again teamed up with Best Lawyers …
Jeff Shapiro will be speaking on “Fundamentals of FDA Regulatory Device Law” and on “Overview of Device Regulation” at ACI’s FDA Boot Camp Devices Edition. Chicago, IL
Jeff Shapiro is speaking at the Orthopedic Surgical Manufacturer’s Association Fall Meeting on “Advertising and Promotion”. Arlington, VA
Kurt Karst will be speaking on “Making the Case for An Rx to OTC Switch: Legal and Regulatory Considerations” at ACI’s Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs. The Carlton Hotel New York, NY
Kurt Karst is a co-speaker at ACI’s Maximizing Pharmaceutical Patent Lifecycles conference for the session: “Exclusivities and Forfeitures: New Developments, Controversies, and Related Concerns”
James Ellison is speaking on “Bolstering Trial Strategy in Litigation over AMP Calculations to Mitigate Exposure” at the ACI’s National Forum on Pharmaceutical Pricing Litigation. Carlton Hotel New York, NY
Anne Walsh is a moderator for the session on “Trends and Priorities in Enforcement: Updates from HHS OIG and DOJ Officials” at the FDLI Advertising and Promotion Conference. Capitol Hilton Hotel Washington, DC
On July 9, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA significantly affects both pharmaceutical and device manufacturers. It has a direct impact on all in vitro diagnostic (IVD) manufacturers, and for IVD companies developing companion diagnostics, …
Device companies do not lack advice or resources to help meet Food and Drug Administration (FDA) requirements. FDLI’s extensive publications present a wealth of information, and this is only one source of many. Sometimes, what companies need most is advice on how to take this …
Kurt Karst is a co-presenter for the session on “Demystifying the Scope and Potential Impact of Proposed Legislation on Biosimilars to Enable You to Make Strategic Decisions Now” at the C5 EU Pharma Regulatory Law conference. Le Meridien Hotel, Brussels
The U.S. Pharmacopeial Convention (“USP”) recently announced at an Awards and Recognition Program for USP Expert Volunteers that the 2012 USP Award for an Innovative Response to Public Health Challenges went to the Food Ingredients Expert Committee. Hyman, Phelps & McNamara, P.C. Director Diane …
Diane McColl is speaking on “Oversight/Governance: Over an Increasingly Complex Food-scape” at the USP Science and Standards Symposium: Functional Foods and Dietary Supplements-Global Opportunities and Challenges. Boston Renaissance Waterfront Boston, MA
Ricardo Carvajal is a panel member for “Compliance Challenges” and “Enforcement Hot Topics ” at the The Food, Drug & Cosmetic Division of the American Society for Quality 23rd West Coast Conference Dietary Supplement Global Strategies. Disneyland Hotel at Disneyland Resort Anaheim, California
Katie Bond presenting “Truth Stranger Than Fiction: Recent Developments in Dietary Supplement Litigation, Regulation and Truth in Advertising” at the Eighth Annual Nutrition Law Symposium.
Wes Siegner is speaking on “FDA Update – Enforcement 2012: Things You Need To Know” at the Eighth Annual Nutrition Law Symposium. Thanksgiving Point Gardens 3900 North Thanksgiving Way Lehi, UT
Jeff Gibbs is a panelist for the Round Table Discussion: “Best Practices in Working with FDA Reviewers to Secure Regulatory Approval” at the Clinical Affairs and Regulatory Approvals for Diagnostics Conference. Hilton Alexandria Mark Center Alexandria, VA
Kurt Karst will conducting the PLI webinar on “Are You Ready to Enter the U.S. Biosimilars Pathway?” 1:00 to 2:00 pm EST
Jeff Shapiro is conducting Thompson Interactive’s webinar on Changes to the FDA’s 510(k) Clearance Process Webinar 1:00 pm ET/12:00 pm CT/11:00 am MT/10:00 am PT Duration: 90 minutes
In this article, published in the July 2012 issue of Scrip Regulatory Affairs, Jeff Shapiro explains why medical device companies whould benefit from regular and detailed Food and Drug Administration 510(k) decision summaries.
Ricardo Carvajal is speaking on “Phosphorous Labeling in the U.S. – Regulatory Considerations” at the Dietary Phosphorus Consensus Conference. Honolulu, HI
Jeff Gibbs is a panelist for the “Legal Jeopardy from the Conduct of Clinical Trials” session at the DIA Annual Conference. Philadelphia, PA
Kurt Karst will be speaking on “Orange Book Listings, De Listings and Related Challenges” at the ACI Hatch-Waxman Boot Camp. San Diego, CA
12:30 – 2:00 p.m. ET This webinar will feature HPM attorneys Doug Farquhar, John Fleder, and Anne Walsh, who bring the full perspective of experience in government enforcement, including a former Assistant U.S. Attorney, the former Director of DOJ’s Office of Consumer Litigation, and a former …
This presentation features HPM attorneys Doug Farquhar, John Fleder, and Anne Walsh, who bring the full perspective of experience in government enforcement, including a former Assistant U.S. Attorney, the former Director of DOJ’s Office of Consumer Litigation, and a former Associate Chief Counsel at FDA. …
Dara Katcher Levy is a panel member for the session on “Importing FDA Regulated Goods: Satisfying New Safety Requirements and Agency Compliance Expectations” at the ACI Import Compliance & Enforcement conference. DoubleTree Hotel Washington, DC
Jeff Shapiro is conducting a webinar on “Discovering the Impact of the FDA’s Eagerly Awaited Final Risk-Benefit Guidance” 1:00 to 2:30 pm