The U.S. Food and Drug Administration is implementing a new transparency initiative to release complete response letters (CRLs) shortly after sponsors receive them. Building on July's unprecedented publication of over 200 CRLs, the agency has now posted an additional batch of 89 letters from 2024 onwards, providing greater insight into regulatory decisions, including notable rejections in gene and cell therapies. Concurrently, the FDA announced plans to increase surprise inspections at foreign drug manufacturing sites to align with domestic oversight practices, aiming to strengthen the quality and safety of global pharmaceutical supply chains.