Glossary

What is an AdCom (FDA advisory committee meeting)?

A panel of outside experts that votes on questions the FDA puts to it ahead of a decision.

An advisory committee (AdCom) is convened when the FDA wants outside expert input — usually for close calls, novel mechanisms, or safety controversies. The committee hears data, asks the sponsor questions, and votes on questions like 'do the benefits outweigh the risks.'

The FDA is not bound by the vote, but it usually follows it. AdCom outcomes are scheduled, public, and heavily traded — a negative vote days before a PDUFA date is one of the sharpest single-day moves in the sector.

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