On September 4, 2025, the US Food and Drug Administration (FDA or the Agency) announced that it released a second batch of complete response letters (CRLs) — which explain the Agency’s determination for refusing to approve a new drug application (NDA) or biologics license application (BLA) in its then-present form — to its new public CRL database. FDA published its first batch of CRLs to this database in July 2025. While FDA’s initial release was limited to CRLs issued for product applications that were ultimately approved, this second release consists of 89 CRLs associated with “pending or withdrawn” applications that were not ultimately approved.
FDA had not previously published these 89 CRLs. Going forward, FDA stated that it intends to publish additional batches of previously issued CRLs associated with withdrawn or abandoned applications as well as future CRLs promptly after they are issued to the product’s sponsor.
Consistent with the batch released in July, the CRLs published on September 4 identify the sponsor recipient. However, the CRLs are redacted to omit what FDA characterizes as confidential commercial information, trade secrets, and personal private information. Each of these categories of information is generally protected from Agency disclosure under federal law. FDA stated that it will continue to apply redactions for these categories of information going forward.
FDA has not described how it applied these redactions or will apply them going forward. For example, FDA has not clarified whether its recently launched AI tool, Elsa, was used to apply redactions.
The CRL database homepage acknowledges the information disclosure regulations that govern FDA’s authority to release CRLs. However, it is unclear whether or how FDA confirmed that disclosure of unapproved application CRLs complies with such information disclosure regulations. For example, 21 C.F.R. § 314.430 prohibits public disclosure of application information for unapproved applications that have not been publicly disclosed or acknowledged, suggesting that the Agency would have been required to confirm that all of the applications identified in the 89 CRLs released on September 4 had been previously disclosed or acknowledged.
FDA has also not clarified how compliance with its information disclosure regulations, including § 314.430, will limit FDA’s future disclosures of CRLs promptly after issuance to the product sponsor.
Product sponsors should brace for the impacts of FDA’s new transparency initiative to release previously non-public CRLs. CRLs contain detailed feedback from FDA regarding the deficiencies in the application that preclude approval, often including technical analysis of data limitations or manufacturing concerns and FDA’s recommendations to address the deficiencies identified. Even redacted versions can provide sensitive information that can be used to expedite a competitor’s strategy or advance litigation, including securities litigation for public companies whose CRLs are newly published by FDA.