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U.S. Department of Health and Human Services

About FDA

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Do patients and caregivers have a role in the approval process?

En Español

Yes, FDA is committed to including the patient perspective in medical decision-making. FDA developed two programs to give patients a more active role in medical product development and regulation.

  • The Patient Representative Program brings the patient voice to FDA advisory committee meetings to ensure input into important medical product review and policy questions.
  • The Patient Consultant Program includes the patient voice early in the medical product development process during meetings between FDA and product sponsors (developers).
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