Non-Approval in the Sunlight: FDA’s CRL Disclosures, the Limits of Confidentiality, and Lessons from the EMA

FDA’s 2025 disclosure of complete response letters (CRLs) represents a shift from historical treatment of CRLs as confidential, though the agency has not committed to a specific posting timeline for future disclosures. Drawing on a comparison with the European Medicines Agency’s more standardized disclosure practices, the authors recommend that FDA codify disclosure timelines and redaction standards, provide neutral summaries of CRLs when redactions obscure the basis for non-approval, and standardize the inclusion of prior-cycle CRLs in drug approval packages.