Advisory Committee (FDA)
An independent panel of outside experts convened by the FDA to provide recommendations on drug approval decisions. Advisory committees review clinical data and vote on whether a drug's benefits outweigh its risks. Their recommendations are influential but not binding on the FDA.
Technical Context
FDA advisory committees are composed of external experts (physicians, scientists, patient representatives, statisticians, and a consumer representative) who provide independent recommendations on specific drug applications or policy questions. Key committees for peptide drugs: Endocrinologic and Metabolic Drugs Advisory Committee (GLP-1 RAs, GH products, metabolic peptides), Oncologic Drugs Advisory Committee (proteasome inhibitors, radiopharmaceuticals), and Antimicrobial Drugs Advisory Committee (antimicrobial peptides). Advisory committee meetings are public, with presentations from the FDA review team, the sponsor, and public speakers. Voting is recorded but advisory — the FDA is not bound by committee recommendations (though it usually follows them). Meetings occur when: the benefit-risk is borderline, the drug represents a novel mechanism or indication, or significant public interest exists. Advisory committee briefing documents provide detailed FDA and sponsor analyses and are publicly posted before the meeting.