In a move toward regulatory openness, the FDA released over 200 complete response letters (CRLs) corresponding to drug application denials, marking a step in the agency's modernization and transparency efforts. The published correspondence provides insight into FDA's review processes and common deficiencies leading to non-approval. Limitations remain concerning redactions and contextual disclosures. This initiative follows FDA Commissioner Marty Makary’s tenure focus on enhancing agency transparency and regulatory efficiency.