AdCom

Also known as: Advisory Committee, FDA AdCom

An external expert panel that votes on whether the FDA should approve a contested drug.

Definition

An FDA Advisory Committee (AdCom) is a public meeting where independent clinicians, statisticians, and patient representatives vote on the benefit-risk balance of a drug under review. The FDA is not bound by the vote but follows it ~85% of the time. AdCom votes are major market catalysts. Examples: aducanumab (Aduhelm) 10–0 against (2020), still approved; Leqembi unanimously in favour (2023).

See also

• CRL — The FDA notification that an NDA or BLA cannot be approved in its present form.

Other regulatory terms

• NDA
• BLA
• PDUFA date
• Priority review
• Breakthrough Therapy
• Accelerated approval