MedPage Today September 5, 2025
Agency published new batch of 89 letters, promises to start posting them in real time
The FDA on Thursday promised to start posting its drug rejection letters shortly after they’re issued to the pharmaceutical companies sponsoring the products.
The agency also published 89 of the so-called complete response letters (CRLs) issued since last year that are associated with pending or withdrawn applications, which followed a batch of 200 in July. The letters are now accessible via a public database, though with redactions for trade secrets, private personal details, or other confidential information.
“This is a milestone day for the agency,” said FDA Commissioner Marty Makary, MD, MPH. “By embracing radical transparency — one of the guiding principles of this administration...
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