The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. This ongoing release of CRLs follows the July 2025 creation of a public database for CRLs for drug and biologic applications that have been approved. To start this process, on Thursday, FDA posted 89 CRLs to its openFDA database. According to FDA, going forward, the agency will promptly publish newly issued CRLs for unapproved applications. FDA will also publish all CRLs for an application when approving an application, as well as batches of CRLs for abandoned or withdrawn applications. Below we summarize FDA's announcement, and point out some of the questions remaining over this public disclosure process.
In July, we analyzed FDA’s publication of more than 200 complete response letters (CRLs) issued between 2002 and 2024. At the time, the agency notably only published CRLs sent to companies whose drug and biological products had eventually been approved. We highlighted that one significant question at that point was whether FDA would expand this practice to documents protected as confidential.
Now, FDA has announced that it will release future complete response letters (CRLs) “promptly” after they are issued to sponsors. FDA will release all prior CRLs associated with an application when approving an application for a New Drug Application (NDA) or Biologics License Application (BLA). FDA also plans to publish batches of CRLs associated with withdrawn or abandoned applications. On Thursday, FDA released 89 previously unpublished CRLs issued from 2024 on associated with pending or withdrawn applications.
FDA Commissioner Dr. Marty Makary hailed the new release of CRLs as “a milestone day for the agency,” continuing to pledge “radical transparency” and “complete context to investors and shareholders.” FDA states that the release of all CRLs complies with Executive Order No. 14303, “Restoring Gold Standard Science,” which mandated that agencies 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.”
Confidentiality and other concerns
In July, FDA said the publicly released letters “were redacted for trade secrets and confidential commercial information.” Again this week, FDA promised that “CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, but will contain company names.” A cursory review of the CRLs in the database indicates that some redactions have been made.
Despite the heightened confidentiality interests for communications regarding pending applications, we are not aware of any sponsors that have been contacted to confirm that all trade secret and confidential information has been redacted. CRLs may include detailed technical assessments, refer to proprietary technology, or expose clinical development strategies that applicants may not want to make public. Even redacted, a CRL can contain hints, or even details, about an applicant’s internal decision-making, intellectual property strategy, or technological hurdles.
As a result, upon receipt of a CRL, we urge sponsors to consider proactively notifying FDA of any confidential commercial or trade secret information or TSI in the CRL.
Open questions remain regarding whether:
- FDA will provide guidance to industry on the redaction process and what the agency plans to disclose moving forward;
- litigation may be brought against the agency related to the CRL disclosures, including potential challenges raised about the adequacy of the FOIA staff’s review and redaction of the CRLs;
- securities litigation may be levied by investors alleging information in the CRLs does not line up with previous company statements, or in product liability suits using newly disclosed information;
- outside groups will use the CRLs to attempt to engage with FDA on pending applications.
We will continue to keep you apprised of additional CRL releases, and other updates that may arise as we continue to monitor FDA’s evolving transparency policies. FDA’s CRL database is available online here.
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