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FDA Advisory Committee (AdCom) meetings

Updated ·next FDA decision on the calendar

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.

An FDA advisory committee is a panel of outside experts convened to review the evidence for an application and vote on questions the FDA poses. The vote is advisory rather than binding; the FDA usually follows it but is free not to. Panels are typically convened for novel, contested, or high-profile applications.

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.

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