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What is an FDA Advisory Committee

FDA Advisory Committees are created when a scientific, technical, or policy question is raised. They help determine whether an unapproved product is safe and effective. The FDA often relies on Advisory Committees to provide independent advice. Committee members include scientific experts such as physicians, statisticians, and members of the public, including an FDA Patient Representative.

The two main objectives of the FDA advisory committee is to:

  • Offer independent expert advice to the FDA in its evaluation of these regulated products.
  • Assist the FDA to move toward making objective decisions based upon the reasonable application of sound scientific principles.

FDA Advisory Committees weigh the available evidence and provide scientific and medical advice on the safety, effectiveness, and appropriate use of products that the FDA regulates. Oftentimes committees are asked to provide advice on general topics that may not be related to specific products.

The advice that the FDA receives from the committee does not represent the position of the FDA, rather, the FDA weighs the advice that it receives when taking actions on medical products. The FDA makes the final decisions on all matters that come before the committee.

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