The FDA has published over 200 complete response letters (CRLs), revealing reasons for drug application rejections between 2020 and 2024. These letters, for products later approved, provide insights into the FDA’s common concerns including safety, efficacy, and manufacturing issues. While some redactions remain, the move marks a significant transparency shift in regulatory communications. Industry stakeholders see the disclosure as a step towards more predictable drug development pathways. The agency plans to release further CRLs to continue enhancing public understanding of its decision-making.