The U.S. Food and Drug Administration (FDA) has initiated a major policy shift by committing to publish complete response letters (CRLs)—official documents explaining drug application rejections—concurrently with their issuance to sponsors. Following a July release of over 200 CRLs, the agency disclosed an additional 89 letters from 2024 to 2025, including high-profile rejections for gene therapies and oncology treatments. Commissioner Marty Makary emphasizes this move as a step towards radical transparency, improving public trust in drug evaluation processes while satisfying executive mandates on scientific data communication. This policy enhances insights into the FDA's decision-making, providing clarity for developers and stakeholders on regulatory expectations and unresolved safety or efficacy concerns for ongoing drug applications.