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FDA Advisory Committee (AdCom) meetings

An FDA Advisory Committee (AdCom) is a panel of independent outside experts the FDA convenes to review a drug and vote on questions like whether the benefits outweigh the risks. The vote is non-binding — but the FDA usually follows it, so AdComs are major catalysts in their own right, typically held weeks before the PDUFA date.

Why AdComs matter to traders

An AdCom can move a stock as much as the decision itself. The FDA often posts its own briefing documents a couple of days before — another scheduled, market-moving sub-catalyst.

Not every drug gets one

The FDA reserves AdComs for novel, controversial, or first-in-class questions. No AdCom can itself be read as routine — or as the FDA being confident. See upcoming dates on the calendar.

See the live FDA PDUFA calendar →

FAQ

Is an FDA advisory committee vote binding?
No. The vote is a recommendation. The FDA usually follows it but is not required to.
When is the AdCom relative to the PDUFA date?
Usually a few weeks to a couple of months before the PDUFA decision date.

Related

What is a PDUFA date?
What is a Complete Response Letter (CRL)?
Priority Review vs Standard Review
What happens to a stock on its PDUFA date?
2026 PDUFA calendar
Every upcoming FDA decision by month.
FDA decisions archive
Past approvals & CRLs.