The U.S. Food and Drug Administration (FDA) has taken a decisive step toward transparency by committing to publish complete response letters (CRLs) to drugmakers promptly after issuance. Following an initial unprecedented release of over 200 CRLs in July, the FDA disclosed an additional batch of 89 previously unreleased letters dating from 2024 to 2025, including rejections involving prominent developers such as Replimune, Capricor Therapeutics, and Ultragenyx. FDA Commissioner Marty Makary emphasized the public's interest in agency decision-making transparency and the adherence to an executive order mandating communication of scientific data. This development sheds new light on the agency's regulatory decision processes and sheds fresh insight into prior controversial rejections, such as Zealand Pharma’s glepaglutide in short bowel syndrome, highlighting concerns about data inconsistencies and unreported adverse events.