FDA to publish in real time all Complete Response Letters, releases batch of 89
The U.S. Food and Drug Administration (FDA) will now release complete response letters (CRLs) in real time, the agency announced Sept. 4. In its first step under the new policy, the FDA published 89 previously unpublished CRLs issued between 2024 and the present.
Each letter outlines safety or effectiveness deficiencies that prevented an application from receiving approval. Future CRLs will be posted promptly after issuance, and when an application is approved, all prior CRLs associated with that application will also be made public. Letters tied to withdrawn or abandoned applications will be published in batches, the agency said. All documents will be redacted for confidential commercial information and personal identifiers, but company names will remain visible.
“This is a milestone day for the agency,” FDA Commissioner Marty Makary said in a statement. “By embracing radical transparency — one of the guiding principles of this administration — we’re giving invaluable insights to help speed therapies and cures to market, providing complete context to investors and shareholders, and above all, restoring public trust.”
The FDA said making CRLs public will help drug developers avoid common missteps, provide patients and health care providers with better insight, and ensure investors receive complete information. The initiative also complies with Executive Order No. 14303, which directs agencies to release data and analyses that significantly affect public policy or private-sector decisions.
The move builds on the agency’s July release of more than 200 CRLs issued between 2020 and 2024. As Pharma Manufacturing reported at the time, 74% of those letters cited quality or manufacturing issues, including problems with facilities, inspections, or chemistry, manufacturing and controls. Several companies — including Eli Lilly, Pfizer, Teva, and Dr. Reddy’s — received multiple letters during that period.
The FDA said decision letters are now accessible as a centralized dataset on openFDA.