The FDA’s policy to publish complete response letters (CRLs) is running into legal uncertainty, according to discussion of the initiative’s status and risks. While the policy was previously described as a transparency win for developers, investors, and patients, experts cited ongoing questions about whether the agency can disclose CRLs for applications still subject to confidentiality rules. Legal professionals pointed to regulatory provisions that treat the existence of an application as confidential, raising concerns that publishing CRLs for submissions that are not already public could conflict with FDA rules. The reporting also notes a sequence of announcements and course changes suggesting the legal basis is evolving rather than settled. The issue has drawn attention from law firms involved in petitions and commentary, including concerns that litigation could follow. The FDA has also been considering rulemaking to solidify the policy’s foundations through amendments linked to CRL releases.