The U.S. Food and Drug Administration (FDA) has initiated a transparency measure by publishing over 200 rejection letters, known as complete response letters (CRLs), related to drug applications that were eventually approved. This marks the first time at least 14 of these letters have been made publicly available in a consolidated and accessible format, addressing previous challenges where disclosures were scattered and difficult to locate. FDA Commissioner Marty Makary has advocated for this transparency to counteract the historical lack of openness in FDA decision-making, which allowed companies to selectively disclose information to investors and shareholders. Despite this progress, the published letters currently cover only drugs that ultimately received approval. Separately, the FDA is intensifying scrutiny on kratom extracts and is preparing to request expanded authority from Congress to better regulate illegal vaping imports, citing inadequacies in current enforcement tools. The agency is also contending with internal challenges, including layoffs and leadership transitions, as it navigates ongoing controversies such as the Sarepta Therapeutics Duchenne therapy situation and debates surrounding mRNA vaccine approvals. New leadership under CDER Director Tidmarsh faces industry expectations to restore stability amid these issues.