The U.S. Food and Drug Administration is intensifying efforts toward transparency and regulatory modernization. The agency is now releasing complete response letters (CRLs) to drug sponsors shortly after issuance and has published a historical batch of 89 previously unreleased CRLs covering 2024 to 2025. This shift accompanies announcements of increased unannounced foreign drug manufacturing inspections to uphold quality standards. Complementing these initiatives are policy updates such as real-time CRL disclosures starting soon and ongoing probes into COVID-19 vaccine safety in children, illustrating FDA’s commitment to public trust and regulatory rigor.