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  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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