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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. General CMA Pilot 2 program criteria text box
  1. Prescription Drug User Fee Amendments

General CMA Pilot 2 program criteria text box

General CMA Pilot 2 program criteria: • Product must be Fast-Track • Must have had an End-of-Phase 1, or equivalent meeting • Must not be on clinical hold • Only one Pilot 2 product per CDER/CBER review division Other FDA considerations for applicants: • Potential value of enhanced interaction (public health benefit resulting from development of the product) • Likelihood that concentrated scientific dialogue will facilitate the availability of a promising novel therapy • Demonstration of commitment to product development

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