Expertise in all things FDA
American Conference Institute InterContinental The Barclay New York, NY Jeff Gibbs presenting Regulation and Dissemination of Off-Label Information on May 16th. Overview of the FDA’s regulation of off-label promotion How can information on off-label or nonapproved uses of drugs and biologics be disseminated? peer review articles v. ghost-writing MSLs v. sales …
Brian Donato will be speaking at the USC Regulatory Science Program on Business Ethics in the Medical Products Industry.
Doug Farquhar will be presenting at the FDLI 5th Annual FDLI Enforcement and Litigation Conference. Compliance Officers, Manufacturers of Unapproved Drugs and Devices, or Marketers? Who will be the next FDA target? The Madison Hotel 1177 Fifteenth Street, NW Washington, DC 20005 (202) 862-1600
Brian Donato is one of the faculty for the 26th Annual National Trial Advocacy College, held at University of Virginia’s School of Law in Charlottesville. He will be teaching and demonstrating “Trial Tactics and Techniques”.
A. Wes Siegner, Jr. Speaking at FDA Functional Foods Public Hearing beginning at 9 a.m. in the Center for Food Safety and Applied Nutrition’s Harvey W. Wiley Auditorium in College Park, Maryland.
Anne Marie Murphy will be presenting at the FDLI & CDG e-conference How to do Post-Approval Registry Studies for Medical Devices 11:00 am to 1:00pm, Central Standard Time
Jeff Gibbs will be presenting at the AHLA Conference: Life Sciences – Fundamentals of Health Law Palmer House Hilton Chicago, IL
Dara Katcher will be presenting: Import & Export Requirements & International Issues at the FDLI: Introduction to Drug Law & Regulation Understanding How the Government Regulates the Drug Industry November 6-7, 2006 The Washington Court Hotel Washington, D.C.
IFT/University of Massachusetts Symposium The Path Forward for Functional Foods: Exploring Scientific and Legal Solutions for Defining Efficacy Diane McColl presenting: Demonstrating Current System for Health Claim Efficacy – Examples, Problems and Potential Solutions
Brian Donato will be lecturing at the University of Southern California, School of Pharmacy for their Regulatory Science Course: Medical Products and the Law. Mr. Donato has been a guest lecturer for USC in the past. He will be covering agency enforcement powers.
Marriott Bethesda North Hotel and Conference Center North Bethesda, Maryland Robert A. Dormer will be a speaker at the conference.
The Westin Kierland Scottsdale, Arizona
FDC Reports Audioconference Patentbusters – The Uncertain Future of Branded and Generic Drugs in the Wake of Plavix and Apotex October 12, 2006 Time: 2:00 p.m. EDT Bob Dormer is one of the featured speakers.
PLI: Pharmaceutical Law 2006 – Across The Product Life Cycle PLI New York Center New York, NY Josephine M. Torrente presenting: Overview of the Legal Issues During Research and Development
IFT: A Global Perspective on the Safety and Regulatory Approval of Food Ingredients Diane B. McColl presenting Routes to the U.S. Market Health-Related Claims in the U.S.
Bob Dormer is a keynote speaker at the FMMC 2nd Annual Medical Devices Symposium in Tampa. His topic is “Recent Trends in FDA Medical Device Enforcement”
John A. Gilbert will be the lead speaker for the Heathcare Distribution Management Association (HDMA) Webinar entitled Pseudoephedrine and Dextromethorphan Regulatory Review. This webinar will provide a regulatory review of all state and federal requirements for pseudoephedrine and dextromethorphan, an analysis of anticipated 2007 legislative and …
Hyman, Phelps & McNamara is sponsoring and Wes Siegner will give a presentation at the Second Annual Nutritional Law Symposium in Salt Lake City, Utah.
Medical Device Regulation: Getting to the Market and Navigating the Regulatory Pitfalls, A symposium sponsored by Hyman, Phelps & McNamara, P.C. May 11, 2006 Hyatt Regency Irvine Irvine, CA