Page updated ·next FDA decision on the calendar·Data as of Nov 10, 2026 12:55 AM ET
The FDA's public release of complete response letters holds 3 letters dated September 2025 (openFDA, last updated 2026-08-26). Of the 17 FDA decisions on PDUFA goal dates pdufa.bio tracked in September 2025, 4 were Complete Response Letters.
A Complete Response Letter is the FDA's notice that it will not approve an application in its current form; it is not a permanent rejection, and the sponsor can resubmit. The two counts come from different records and are not added together. ← August 2025 · October 2025 → · all released letters · every CRL decision we tracked
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