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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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  3. FDA User Fee Programs
  4. Prescription Drug User Fee Amendments
  5. Exhibit 4-1 long description
  1. Prescription Drug User Fee Amendments

Exhibit 4-1 long description

Seven out of 8 companies stated that an expected benefit of the program was the 6-month review clock and 2 or the 8 companies expected increased press coverage. Five of the 8 sponsor's cited earlier approval as a desired benefit and 2 of the 8 said that increased communication was a desired benefit.

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