ADVISORY COMMITTEE CONFLICT-OF-INTEREST WAIVER THRESHOLD OF $100,000
Executive Summary
ADVISORY COMMITTEE CONFLICT-OF-INTEREST WAIVER THRESHOLD OF $100,000 is recommended in FDA's "Policy & Guidance: Handbook for FDA Advisory Committees" released June 10. In an appendix on "general principles for excluding SGEs [special government employees] from participating in advisory committee meetings," the agency states that, if an advisory committee member holds a "substantial" interest in a sponsoring company or a competitor, "exclusion appears to be the only course for both members and consultants."