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 4 letters dated July 2026 (openFDA, last updated 2026-08-26). Of the 14 FDA decisions on PDUFA goal dates pdufa.bio tracked in July 2026, 0 were Complete Response Letters.
Complete Response Letters among decisions pdufa.bio tracked · 0
None: the 14 tracked decisions this month were approvals.
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. ← June 2026 · August 2026 → · all released letters · every CRL decision we tracked
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.