Overview
- Going forward, the FDA will publish complete response letters promptly after issuing them to sponsors.
- The agency has posted 89 previously unpublished letters from 2024 to the present on the OpenFDA database.
- When a product is approved, the FDA will release all prior letters tied to that application and will also batch-publish letters for withdrawn or abandoned filings.
- Published letters will be redacted to remove trade secrets and personal data while disclosing company names, and early reviews show clinical and statistical findings are often visible as manufacturing details are mostly redacted.
- The FDA says the policy aims to speed learning across industry and provide better context to patients, physicians, and investors, even as sponsors have historically opposed public disclosure.