The U.S. Food and Drug Administration (FDA) has for the first time publicly released over 200 complete response letters (CRLs) issued between 2020 and 2024 as part of a transparency initiative. These letters detail the agency's reasons for initial drug application rejections, covering both branded and generic medicines, including safety, efficacy, manufacturing, and bioequivalence concerns. The published letters are for drugs that were ultimately approved, with some text redacted to protect confidential information. FDA Commissioner Marty Makary emphasized this step as delivering on a promise of radical transparency, allowing drug developers and investors better insight into FDA decision-making. The agency plans to continue releasing more CRLs to improve predictability and understanding in the drug approval process.