PharmaAudioconference: Agenda

Audioconference Agenda

National Pharma Audioconference: The Future of Food and Drug Regulation - A Conversation With Peter Barton Hutt,"the Unofficial Dean of Washington Food and Drug Lawyers"

Thursday, October 27, 2005

1:00 pm - 2:30 pm (Eastern)
12:00 pm - 1:30 pm (Central)
11:00 am - 12:30 pm (Mountain)
10:00 am - 11:30 am (Pacific)

The Audioconference agenda is set forth in Eastern Daylight Time below:
1:00 pm	Welcome and Introduction Nancy Singer, Esq. (Moderator)
1:15 pm	Comments of Peter Barton Hutt, Esq. regarding the Current Regulatory Climate and its Effect on the Pharmaceutical and Medical Device Industries Peter Barton Hutt, Esq. The effect that each Commissioner has on the daily operations of the FDA, What to do when FDA seems reluctant to take any action on a product application, How to appeal an adverse decision, How to deal with a hostile investigator or reviewer, The effect that Congress, the press, and patient groups have on agency decisions, The regulatory risk of off-label promotions, and The effect that the "new" risk management initiative will have on FDA in 2006
2:00 pm	Panel Response and Questions and Comments Richard DeRisio, Patricia Garvey, Ph.D., Ron Geigle and Nancy Singer, Esq.
2:30 pm	Audioconference Adjournment