PharmaAudioconference: Agenda

Audioconference Agenda

National Pharma Audioconference: The Impact of FDA's Draft Guidance on Medical Journal Reprints and Other Recent Developments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

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 Merrill Goozner's Presentation Materials: "Good Reprint Practices for the Distribution of Medical Journal Articles and Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices." Scott Gottlieb's Presentation Materials: Powerpoint or Acrobat
1:35 pm	Questions for Mr. Goozner and Dr.Gottleib
1:45 pm	FDA Perspective Coleen Klasmeier, JD Coleen Klasmeier, Paul Kalb, & Daniel Troy's Presentation Materials: Powerpoint or Acrobat Additional Materials: Medical Information Working Group Comments on the "Good Reprint Practices for the Distribution of Medical Journal Articles and Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices."
1:55 pm	DOJ Enforcement Perspective Paul Kalb, MD, JD Paul Kalb's Healthcare/White Collar Update: Supreme Court Limits The Scope Of FCA Liability; Requires Intent To Cause The Government To Pay A Claim
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