FDA Announces Prompt Disclosure of Complete Response Letters, Release of Additional Letters

The U.S. Food and Drug Administration (FDA) on Sept. 4, 2025, announced the release of 89 previously unpublished Complete Response Letters (CRLs), building on the previous release of more than 200 CRLs on July 10, 2025.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 the CRLs "offers important benefits for public health." These benefits include giving developers tools to avoid common mistakes and hopefully allow developers to bring new technologies to market in a more efficient manner, as well as provide clear communications to developers moving through the FDA processes. The CRLs will be published on openFDA, the FDA's database. Moving forward, the FDA plans to "promptly" release newly issued CRLs associated with applications; however, the agency does not define a specific timeline for these releases.

Consistent with the FDA's previous initiative to release older CRLs, the newly published CRLs are, according to the FDA, redacted to protect confidential commercial information, trade secrets and personal private information. However, the FDA's September 2025 effort includes, for the first time, CRLs issued for pending or withdrawn applications. Sponsor names will be public, and sponsors should continue to monitor any CRLs related to their filings to ensure all necessary information is adequately redacted.

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Holland & Knight's Healthcare Team and Life Sciences Team will continue to monitor these developments and provide updates when appropriate. If you have questions, please contact the authors.

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