Regulatory Process Updated January 14, 2026

What is an FDA Advisory Committee?

FDA Advisory Committees are expert panels providing recommendations on drug approvals. Learn about AdCom meetings, voting, and impact on FDA decisions.

Definition

FDA Advisory Committee (AdCom) is an independent panel of outside experts that provides recommendations to FDA on complex scientific and medical questions, including drug approvals. While FDA is not bound by these recommendations, they carry significant weight.

How Advisory Committees Work

FDA convenes advisory committees for applications requiring external expert input. Meetings are public, and panels vote on specific questions regarding safety, efficacy, and approval.

Major Advisory Committees

CommitteeFocus Area
ODACOncology drugs
CDERCardio-renal drugs
EndocrineMetabolic/endocrine drugs
AMDACAntimicrobials
PCNSPsychiatric drugs

AdCom Meeting Structure

  1. FDA Presentation: Agency overview of application
  2. Sponsor Presentation: Company presents clinical data
  3. Public Comment: Patient advocates and others speak
  4. Committee Discussion: Panel deliberates on data
  5. Voting: Members vote on specific questions

Why BD Teams Track Advisory Committees

For business development professionals, AdCom outcomes affect valuations:

  • Deal Implication: Negative AdCom vote significantly impacts approval probability
  • Due Diligence Focus: Review FDA briefing documents for risk signals
  • Opportunity Signal: Upcoming AdComs create trading and deal opportunities

Frequently Asked Questions

What is an FDA Advisory Committee?

An FDA Advisory Committee is a panel of outside experts that reviews data and provides recommendations to FDA on drug approvals and other regulatory questions.

Are AdCom recommendations binding?

No, FDA is not bound by advisory committee recommendations but typically follows them. FDA can approve drugs despite negative votes or reject despite positive votes.

When does FDA convene an AdCom?

FDA typically convenes AdComs for novel drugs, controversial applications, significant safety questions, or when expert input would benefit decision-making.

What is ODAC?

ODAC (Oncologic Drugs Advisory Committee) is the advisory committee that reviews cancer drug applications.

Can companies present at AdCom meetings?

Yes, sponsor companies present their data and respond to questions. Patient advocates and other stakeholders may also provide input.

Related Regulatory Terms

NDABLAPDUFA DateFDA Approval Letter

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