Expertise in all things FDA
Jeff Shapiro speaking on “When a 510K or PMA Goes Off Track: What Are the Options for Appeal” at the Association of Medical Diagnostics Manufacturers (AMDM) Annual Meeting. Bethesda North Marriott Hotel and Conference Center Bethesda, MD
Hyman, Phelps & McNamara, P.C. is pleased to announce that Linda S. Carter has joined the Firm as a Regulatory Scientist. Linda, who will primarily assist HP&M’s drug development group, brings significant experience and expertise in shaping regulatory policies, particularly Comparative Effectiveness Research, Personalized Medicine, …
Kurt Karst will be speaking on “Disease Subsetting” at the World Orphan Drug Conference. Hilton Embassy Row Washington, DC
Jeff Wasserstein will be speaking on “Our Hearts are a-Twitter: Social Media and Therapeutic Products” at the 54th Annual FDLI Conference. Ronald Reagan Building International Trade Center 1300 Pennsylvania Avenue, NW Washington, DC
Jeff Shapiro will be speaking on “Communicating Effectively with the FDA and Collaborating with the Agency When Implementing a Recall” at ACI’s Drug and Device Product Recalls Summit. The Union League Philadelphia, PA
Kurt Karst will be conducting the Thompson audio conference: Navigating the Orphan Drug Designation Process, & the Benefits of Obtaining Designation. 2:00pm to 3:30 pm
Jeff Wasserstein will be speaking on “Fear Not Pharma: Revolutionizing Your Marketing Strategies to Adapt to Social Media Platforms” at the ACI 9th Expert Regulatory Guide to Advertising, eMarketing and Promotions for the Pharmaceutical Industry conference. The Union League Philadelphia, PA
Josephine Torrente will be speaking on “Expediting Cancer Therapies” at the conference on Regulating the Drug Treatment of Cancer. Sponsored by the University of Washington Schools of Law, Medicine, Public Health & Pharmacy. Room 138 William H. Gates Hall University of Washington Law School Seattle, Washington
Jeff Gibbs moderating the CDRH Breakout Session of the DIA “Marketing Pharmaceuticals 2011: Workshop for Regulatory Professionals and Promotional Review Teams” Washington Marriott Wardman Park Washington, DC
Ricardo Carvajal will be a co-moderator for a session on the impact of the Food Safety Modernization Act at the ABA’s First Annual Workshop on Food and Supplements, Section of Ligation, Food and Supplements Subcommittee of the Products Liability Committee. The Coca-Cola Company 1 Coca Cola Plaza Atlanta, …
Kurt Karst will be speaking on “Generic Drug Preemption” at the Generic Pharmaceutical Association annual meeting. Hilton Orlando Bonnet Creek Orlando, Florida
Jeff Gibbs will be a panelist for the American University Washington College of Law Founders’ event: Personalized Medicine: Ethics, Privacy, DNA and the Future of Medicine 10:00 AM to 3:00 PM American University Washington College of Law, Room 603 4801 Massachusetts Avenue, NW Washington, DC
Jeff Shapiro will be speaking on “Legal Issues in Physician-Owned Device Companies” at the Physicians and Physician Organizations Law Institute. The Cosmopolitan of Las Vegas Las Vegas, NV
Josephine Torrente will be speaking on “The New Drug Approval Process: New Drug Research and Development” at the FDLI Introduction to Drug Law and Regulation conference. The Westin Washington, DC
Kurt Karst will be presenting “New Trends and Challenges in PTE Litigation: Key Cases to Watch” at ACI’s “The Life Sciences Lawyer’s Guide to Patent Term Adjustment and Patent Term Extensions” conference. Downtown Conference Center New York, NY
Ricardo Carvajal speaking on “Unintended Components/Contaminants of Food” at the FDLI Food Week Conference. Washington, DC
BioCentury This Week TV will broadcast a program concerning the latest thinking about how to create a sustainable economic model for both orphan drug developers and payers. The program, titled “The Economics of Orphan Drugs Why Successful Cures Bring Challenges for Patients and …
Jeff Gibbs will be part of the panel on “Aligning The Regulators and Industry To Accelerate Personalized Medicine Benefits” at the Personalized Medicine World Conference. Silicon Valley, CA
Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne K. Walsh has joined the firm as Of Counsel. Prior to joining the firm in January 2011, Ms. Walsh served as an Associate Chief Counsel with the U.S. Food and Drug Administrations Office …
Doug Farquhar and John Fleder will be conducting the audio conference: Are Attorneys the FDA’s New Enforcement Target? 2:00 pm ET Duration: 60 minutes
Diane McColl has been elected Vice-President of the Council of the International Society for Regulatory Toxicology and Pharmacology (“ISRTP”). ISRTP provides an open public forum for policy makers and scientists promoting sound toxicologic and pharmacologic science as a basis for regulation affecting human safety and …
Kurt Karst will be conducting a Pharmalot webinar on “Navigating The FDA Accelerated Approval Process”. 1:00 PM ET Duration: 1 Hour
Jeff Shapiro will be leading the RAPS webinar and simulcast on “Updates on the FDA 510(k) Clearance Process”
Ricardo Carvajal will be one of the speakers for the Personal Care Products Council Webinar: Product Labeling, Assignment Processes and Global Harmonization of INCI Names. 12:30PM to 2:00PM ET
Susan Matthees will be speaking on “Registration and Listing for Medical Devices” at the FDLI Introduction to Medical Device Law and Regulation conference. Westin South Coast Plaza Hotel Costa Mesa, CA
John Gilbert will speaking on “State and Federal Legal Update on Controlled Substances” at the 8th Annual Controlled Substances Industry, Pharmacy and Listed Chemicals Conference. Crystal Gateway Marriott Arlington, VA
Dara Katcher Levy will be speaking on “Analyzing the Current Pharma Communication Landscape” at the Pharmaceutical Compliance: Off-Label Drug Promotion Conference. Philadelphia, PA
Dave Clissold will be presenting “Clinical Data Falsification” at the Fifth Annual FDA Inspections Summit. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road Bethesda, MD 20852
United Therapeutics Corporation (“UTC”), a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions, unveiled a plaque honoring Frank Sasinowski for his contributions to UTC’s development of its REMODULIN (trepostinil) …
Wes Siegner will be speaking on Foods and Dietary Supplements Structure Function Claims and Scientific Substantiation and Enforcement and Compliance: Regulatory Compliance for Food, Dietary Supplement and Medical Food Companies at the RAPS 2010 Conference San Jose McEnery Convention Center San Jose, CA
Jeff Gibbs will speaking on Gene Patents & Diagnostic Tests at the AIPLA Joint Biotechnology Committee/Special Committee on FDA Law Program for the Annual Fall AIPLA Meeting. Marriott Wardman Park Hotel 2660 Woodley Road, NW Washington, DC
Anne Marie Murphy is presenting “Understanding and Navigating Through the Legal Landscape of Early Access Programs” at CBI’s 3rd Annual Congress on Early Access Programs (EAPs). Philadelphia, PA
Kurt Karst will be presenting “FDA Forfeiture Provisions and Review of Strategic Developments” at the CBI Life Sciences Congress on Paragraph IV Disputes. Philadelphia , PA
Doug Farquhar is on the planning committee for FDLI’s Enforcement and Litigation Conference. The Westin Washington, DC
Ricardo Carvajal a breakout session on Food and Dietary Supplements at the FDLI Enforcement and Litigation Conference. The Westin Washington, DC
Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic. You can register for the free webinar here. (Please register by September 29th.) In criminal prosecutions of corporate executives, …
Dave Clissold will be presenting a Webinar on “Opioid Class REMS: What’s Next?” for the Drug Information Association. 11 am to 12:30 pm
Kurt Karst will be presenting “Nature of the Approval Process” at ACI’s FDA Boot Camp. Seaport Hotel Boston, MA
Paul Hyman will be presenting “Claim Substantiation” the Food, Drug, & Cosmetic Division of the American Society for Quality 21st West Coast Conference. Anaheim, CA
Jeff Gibbs will be presenting at the European Pharmaceutical Regulatory Law conference. London, England
Kurt Karst will be speaking on “FDA Update” at the Specialty Pharma Association fall conference. San Diego Marriott Hotel & Marina San Diego, CA
Kurt Karst will be participating in the panel discussion “As the Drug Patent Landscape Evolves, Strategic Challenges and Opportunities Develop” at the Rodman & Renshaw Global Investment Conference – 12th Annual Healthcare Conference. New York Palace Hotel New York, NY
Jeff Gibbs will be speaking on “FDA Regulation of Protein-Based Diagnostic Tests” at the Cambridge Healthtech Institute’s Accelerating Development & Advanceing Personalized Therapy Conference. Hyatt Regency Crystal City Arlington, VA
Kurt Karst will be presenting “New Trends and Challenges in PTE Litigation: Key Cases to Watch” at the ACI Life Sciences Lawyer’s Guide to Patent Term Adjustment and Patent Term Extensions conference. Downtown Conference Center New York, NY
Jeff Gibbs will be moderating the FDLI Webinar on FDA’s (Emerging) Oversight of Laboratory – Developed Tests. 12:30 to 2:00 p.m. ET
Diane McColl will be presenting “Overview of regulation of food ingredients and dietary supplement ingredients in the United States” at the IFT 2010 Annual Meeting and Food Expo. Chicago, Illinois
Ricardo Carvajal will be presenting “Labeling Requirements and Implications for Foods Marketed in the U.S.” and “Food regulation: Evolutionary changes in revolutionary times” at the IFT 2010 Annual Meeting and Food Expo. Chicago, Illinois
Diane McColl has been elected to the U.S. Pharmacopeial Convention’s (“USP’s”) Expert Committee for the Food Chemicals Codex (Monographs – Food Ingredients) for the 2010-2015 cycle. The committee develops new monographs and revises existing monographs and their associated reference materials for food ingredients, as …
Frank Sasinowski has been elected by the the U.S. Pharmacopeial Convention (“USP”) as an At-Large Trustee of the USP Board of Trustees for the 2010-2015 cycle. The Board of Trustees will guide the activities of the USP for the next five years and makes …
Kurt Karst will be presenting “Update on Regulatory Protections Available to Extend Patent Lifecycles: Comparing and Contrasting Europe and US” at the C5 UK conference on Maximising Pharmaceutical Patent Life Cycles. London, UK