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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  4. Prescription Drug User Fee Amendments
  5. General CMA Pilot 1 program criteria text box
  1. Prescription Drug User Fee Amendments

General CMA Pilot 1 program criteria text box

General CMA Pilot 1 program criteria: • Product must be Fast-Track • Typically, no more than four RUs per application • RUs can be submitted up to 12 months prior to complete submission • FDA commits to a 6-month RU review

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