FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89

The U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors.  The agency also released today 89 previously unpublished CRLs issued from 2024 to the present associated with pending or withdrawn applications.  Each of these CRLs detail specific safety and effectiveness deficiencies identified by the FDA as preventing the application from receiving approval.

“This is a milestone day for the agency,” said FDA Commissioner Dr. Marty Makary, M.D., M.P.H.  “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.”

Going forward, the agency will promptly release newly issued CRLs, and when approving applications will release all CRLs associated with that application.  The agency will also publish batches of previously issued CRLs associated with withdrawn or abandoned applications.  All CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, but will contain company names.  Publishing CRLs offers important benefits for public health, including empowering drug developers to avoid common missteps and efficiently bring more cures and meaningful treatments to the American public; delivering greater insight to patients and the health care providers who treat them; and ensuring sponsors provide complete and contextualized information in communications to investors and shareholders.  The FDA recognizes the tremendous public interest in the transparency and credibility of FDA decision-making.  The publication of all CRLs also complies with the President’s direction to all agencies, via Executive Order No. 14303, to release “data, analyses, and conclusions associated with scientific and technological information produced or used by the agency that the agency reasonably assesses will have a clear and substantial effect on important public policies or important private sector decisions.”  Decision letters are accessible to the public as a centralized dataset at: openFDA.