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Audioconference Agenda

National Pharma Audioconference: The Impact of FDA's Draft Guidance on Medical Journal Reprints and Other Recent Developments

  • Tuesday, June 17, 2008
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 Introductory Remarks
Paul Kalb, MD, JD (Moderator)

1:05 pm

Different Views on Policy and Clinical Aspects of Off-Label Regulation
Merrill Goozner and Scott Gottlieb, MD
1:35 pm Questions for Mr. Goozner and Dr.Gottleib

1:45 pm

FDA Perspective
Coleen Klasmeier, JD
1:55 pm DOJ Enforcement Perspective
Paul Kalb, MD, JD
2:05 pm Strategies to Avoid Liability
Daniel Troy, JD

2:15 pm

Questions and Answers
Paul Kalb, MD, JD (Moderator)

2:30 pm

Audioconference Adjournment




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