Jeff Gibbs Speaking at American Conference Institute FDA Boot Camp

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?