The FDA’s policy to increase transparency by publishing complete response letters (CRLs) has run into legal uncertainty, according to reporting that highlights shifting status around the initiative. The policy began with rapid publication of CRLs without full consultation, but legal experts say the agency’s approach may conflict with existing regulations that treat application existence as confidential. Former FDA Commissioner Marty Makary had called the decision a win for stakeholders, but subsequent reporting suggests the legal basis remains contested, with mentions of pauses and resumption. Lawyers cited concerns that publishing a CRL for a publicly undisclosed submission could violate regulatory confidentiality rules. The issue is now framed as a policy design problem—balancing transparency for developers and investors against confidentiality and statutory constraints for unpublic applications. Companies waiting on CRL-related precedents may see the policy’s evolution as a near-term factor in how feedback is communicated post-submission.