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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 4-20 long description
  1. Prescription Drug User Fee Amendments

Exhibit 4-20 long description

The traditional submission and review process entails the first application review, action is taken, the sponsor takes time to address the deficiencies (up to years), the application is resubmitted and it goes through a second review. The Pilot one submission will submit the separate reviewable units for the different disciplines and will receive a discipline review letter as each is completed. Early feedback may allow for issues to be resolved within the first review cycle preventing a second cycle where the re-work may be considerable. At a minimum, if an approvable action is inevitable then the sponsor will have an opportunity to quickly resolve the minor issues within the first cycle making the resubmission less daunting. However, Substantial gaps in time between reviews may cause rework for the earlier reviewer (Pharm/Tox) if there are relevant questions posed by later reviewers (Clinical).

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