The FDA has taken a significant step towards regulatory transparency by committing to publish complete response letters (CRLs) immediately upon issuance to drug sponsors. This initiative follows the release of over 200 CRLs earlier this year and includes an additional batch of 89 letters from 2024 to 2025. The disclosure sheds new light on the agency's decision-making, providing the biotech community and public with unprecedented insights into clinical and regulatory shortcomings behind drug application rejections.