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Audioconference Agenda
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National Pharma Audioconference: The Impact of FDA's Draft Guidance on Medical Journal Reprints and Other Recent Developments
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)
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The Audioconference agenda is set forth in Eastern Daylight Time below:
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1:00 pm |
Welcome and Introductory Remarks
Paul Kalb, MD, JD (Moderator)
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1:05 pm |
Different Views on Policy and Clinical Aspects of Off-Label Regulation
Merrill Goozner and Scott Gottlieb, MD
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1:35 pm |
Questions for Mr. Goozner and Dr.Gottleib
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1:45 pm |
FDA Perspective
Coleen Klasmeier, JD
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1:55 pm |
DOJ Enforcement Perspective
Paul Kalb, MD, JD
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2:05 pm |
Strategies to Avoid Liability
Daniel Troy, JD
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2:15 pm |
Questions and Answers
Paul Kalb, MD, JD (Moderator)
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2:30 pm |
Audioconference Adjournment
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