Overview

• The FDA has posted more than 200 complete response letters from 2020 to 2024 on its OpenFDA platform with trade secrets redacted.
• These letters outline safety and efficacy concerns, manufacturing deficiencies and bioequivalence issues and offer sponsors recommendations for corrective actions.
• Previously kept confidential, the disclosures are intended to prevent companies from repeating errors and to improve development timelines for smaller firms.
• The transparency push builds on Commissioner Marty Makary’s 2025 modernization agenda that includes AI workflow tools, animal testing alternatives and accelerated review pilots.
• The agency is working to expand the archive further by adding historical letters to give stakeholders a comprehensive view of past regulatory decisions.