The U.S. Food and Drug Administration has taken a historic step by releasing an initial batch of more than 200 drug rejection letters, referred to as complete response letters (CRLs). These documents cover FDA feedback issued from 2020 to 2024 for both branded and generic drugs that subsequently received approval. Although extensive redactions remain, the move marks the agency's commitment to improved transparency around drug review decisions, providing sponsors, investors, and the public deeper insight into FDA concerns prior to approvals. Past commissioners had explored such transparency but faced hurdles. While the current release does not include CRLs for drugs never approved, the FDA indicated ongoing efforts to publish more comprehensive correspondence. The letters highlight common deficiencies involving safety, efficacy, manufacturing, and bioequivalence issues. Commissioner Marty Makary emphasized the end of “guessing games” for stakeholders. The policy shift may influence how companies navigate regulatory submissions and public communication moving forward.