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# FDA Pauses Release of Complete Response Letters as it Mulls Policy
- URL: https://www.fdaweb.com/fda-pauses-release-of-complete-response-letters-as-it-mulls-policy/
- Published: 2026-07-08T12:00:00.000Z
- Updated: 2026-09-14T13:42:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161427

FDA has temporarily suspended its controversial practice of publicly releasing Complete Response Letters (CRLs) for rejected drug applications while it evaluates the policy and works to establish a formal regulatory framework governing the disclosures ([see earlier story](https://www.fdaweb.com/fda-moves-to-cement-complete-response-letter-transparency-policy/)).

The pause, according to *Fierce Biotech*, follows the submission of a Covington & Burling [citizen petition](https://www.fdaweb.com/redact-crls-for-unapproved-applications-petition/) in April that was submitted on behalf of an unnamed pharmaceutical company challenging the agency's authority and implementation of the transparency initiative. An HHS spokesperson told the publication that FDA "temporarily paused" releasing new CRLs beginning in April and is "evaluating the process and potential next steps."

The petition urged the agency to immediately establish a formal process for redacting confidential commercial information and trade secrets before releasing CRLs for unapproved drug and biologic applications. It argued that FDA’s new approach exposes highly sensitive information, including detailed clinical deficiencies and FDA recommendations, which competitors could use to shortcut their own development programs.

The most recent CRL posted to the agency's public database relates to FDA's April 22 rejection of AbbVie's investigational botulinum toxin trenibotulinumtoxinE. More recent complete response actions, including FDA's late June rejection of Sobi's investigational gout therapy, have not been publicly released, according to the publication.

Although the public release of new CRLs has been paused, FDA appears to be moving ahead with plans to formalize the policy through notice-and-comment rulemaking.

An agency-planned rulemaking [listed in the recent unified agenda](https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202510&RIN=0910-AJ16&ref=fdaweb.com) as “Proactive Disclosure of Complete Response Letters” would amend FDA regulations governing the confidentiality and disclosure of regulatory correspondence and establish a formal framework for releasing redacted CRLs. It is scheduled for publication as a proposed rule in October.

According to the agency, current regulations already provide substantial discretion to release information contained in CRLs and make clear that FDA's analyses and deliberations reflected in the letters are not the property of the application sponsor. The proposed rule would remove what FDA characterizes as the principal regulatory obstacle to broader disclosure — the assumption that the existence of a previously undisclosed application is itself confidential commercial information.