The U.S. Food and Drug Administration published an initial batch of over 200 complete response letters (CRLs) detailing application deficiencies from drug approval processes between 2020 and 2024. While these letters pertain only to products eventually approved and include redactions for trade secrets, the move marks a significant shift toward transparency. The letters outline common reasons for drug rejections, including safety concerns and manufacturing issues. FDA Commissioner Marty Makary described this release as a step toward ‘radical transparency,’ aiding developers and investors in understanding regulatory decision-making.