CRL Release Update – No litigation war yet, but new Citizen Petition beats the drums April 29, 2026 By Peter G. Dickos & Michelle L. Butler —

https://www.thefdalawblog.com/2026/04/crl-release-update-no-litigation-war-yet-but-new-citizen-petition-beats-the-drums/?utm_source=rss&utm_medium=rss&utm_campaign=crl-release-update-no-litigation-war-yet-but-new-citizen-petition-beats-the-drums Last September, we blogged about FDA’s release of Complete Response Letters (“CRLs”) for unapproved NDAs and BLAs, which since then have continued at a steady clip. We observed that the policy marked a significant change from FDA’s longstanding position that such CRLs were exempt from disclosure under FOIA and FDA’s own regulations, that this shift in policy was accomplished without undertaking expected administrative processes, such as a Federal Register Notice or a docket to solicit public comment, and that litigation may well follow.