The FDA’s move to publish complete response letters has hit legal uncertainty, with experts warning that the agency may need to adjust the policy’s foundation. Reporting around the policy points to concerns about whether disclosure conflicts with FDA regulations that treat application existence as confidential. Lawyers and former FDA leadership cited risks that publishing certain CRLs could be “just not legal,” and multiple stakeholders said the issue remains too complex to be resolved without broader vetting. The FDA has reportedly considered amending the FDCA and publishing a rule to solidify the approach. For biotech and investors, the policy shift can affect how quickly companies understand and communicate regulatory outcomes. The current uncertainty suggests companies may face a moving target in how regulatory rejections are publicly documented.