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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.

U.S. Food and Drug Administration
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  3. FDA User Fee Programs
  4. Prescription Drug User Fee Amendments
  5. Comparison cohort selection criteria text box
  1. Prescription Drug User Fee Amendments

Comparison cohort selection criteria text box

Comparison cohort selection criteria included: • Not a Pilot product • Designated Fast-Track and submitted a portion of the application as a rolling submission • Recent and available data • Products assigned to divisions similar to those of the pilot products

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