A debate over FDA’s “radical transparency” approach to publishing complete response letters (CRLs) is intensifying as legal uncertainty remains unresolved. Coverage notes that the agency began publishing CRLs without prior public consultation, and that the legal basis for the initiative is still unclear. Former Commissioner Marty Makary previously praised the policy, but experts highlighted regulatory-confidentiality conflicts, arguing that publishing CRLs for applications not publicly disclosed could violate FDA rules. Lawyers also warned litigation could follow, and noted the agency has discussed solidifying foundations through proposed FDCA amendments. For drug developers, this affects planning around disclosure timing, investor messaging, and legal risk management—turning CRL publication into an operational and governance issue, not just a communications change.