Jeff Gibbs Speaking at American Conference Institute FDA Boot Camp


May 15, 2007

JW Marriott San Francisco

San Francisco, CA

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?