Lexology September 9, 2025
The U.S. Food and Drug Administration (FDA) on Sept. 4, 2025, announced the release of 89 previously unpublished Complete Response Letters (CRLs), building on the previous release of more than 200 CRLs on July 10, 2025. The FDA also announced that moving forward, it will release real-time CRLs to the public shortly after such letters are issued to sponsors. FDA leaders see this effort as the next step in their goal of “embracing radical transparency.” (For more information about the earlier CRL release, see Holland & Knight’s previous alert, “Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries,” July 15, 2025.)
The FDA emphasized that it appreciates the public interest in its decision-making and that publishing...
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