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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


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