Radical Transparency, Act II: FDA Releases 89 Previously Unpublished Complete Response Letters

Yesterday, FDA announced the publication of 89 previously unpublished Complete Response Letters (“CRLs”), which appears to be the next step in FDA’s effort towards “radical transparency.” The first step was the posting of 200 already-published CRLs on July 10, 2025, which we blogged about here. However, this latest development marks a significant change in Agency policy as the CRLs released yesterday are CRLs issued from 2024 to the present for pending or withdrawn applications. This is the first time such letters for products with pending applications or applications that were not later approved have been publicly accessible. The newly posted CRLs are available on the openFDA database along with the initial batch of letters.

FDA also announced that “[g]oing 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 The agency will also publish batches of previously issued CRLs associated with withdrawn or abandoned applications” (emphasis added). The stated bases for the release were to promote transparency, provide insights to help speed therapies to market, restore public trust, and, notably, ensure that sponsors provide “complete and contextualized information in communications to investors and shareholders,” the latter of which echoes themes of the Executive Order 14303 issued on May 23, 2025 to “restore gold standard science.”

The release of these CRLs will undoubtedly affect both sponsor and Agency practices going forward.  While our review of these CRLs is still underway, we note that it appears the clinical and statistical deficiencies are largely unredacted, while the product quality deficiencies are largely redacted. This is typically the case for CRLs that have been historically posted as part of an approved product’s action package, where clinical and statistical information is less likely to contain confidential commercial information under the Freedom of Information Act, unlike manufacturing information, which usually contains proprietary information about formulations, stability, etc. We will continue to monitor these developments and expect to post more on this topic in the coming days.