The U.S. Food and Drug Administration (FDA) has initiated a groundbreaking policy to publish complete response letters (CRLs), commonly known as drug rejection letters, concurrently with their issuance to sponsoring companies. This reform, a part of the agency's drive toward radical transparency, includes the recent disclosure of 89 previously unreleased CRLs spanning 2024 and 2025. High-profile drug rejections from companies such as Zealand Pharma, Capricor Therapeutics, Replimune, and Ultragenyx have been notably outlined. The FDA's move marks a significant shift in regulatory openness, providing unprecedented insights into the agency's decision-making processes and offering stakeholders clearer guidance on approval hurdles. Commissioner Marty Makary emphasized the public interest in transparent and credible evaluations. This effort aligns with prior commitments and responds to increasing demands from industry and public advocates alike. The initiative also complements new FDA review pathways planned for ultra-rare diseases, streamlining evidence acceptance including single-arm trials and case studies, to expedite therapies for conditions affecting fewer than 1,000 Americans. These steps represent a dual approach to enhancing both regulatory transparency and flexibility, aiming to accelerate access to critical medicines.