Jeff Gibbs Speaking at American Conference Institute FDA Boot Camp

When

March 27, 2007

American Conference Institute

InterContinental The Barclay

New York, NY

Jeff Gibbs presenting Regulation and Dissemination of Off-Label Information on May 16th.

  • Overview of the FDA’s regulation of off-label promotion
  • How can information on off-label or nonapproved uses of drugs and biologics be disseminated?
    • peer review articles v. ghost-writing
    • MSLs v. sales reps
  • What are the consequences of inappropriate off-label promotion?
    • what is the role of the OIG in monitoring off-label use?