Jeff Gibbs Speaking at American Conference Institute FDA Boot Camp
WhenMay 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?