FDA Publishes Complete Response Letters from 2020–2024 to Promote Transparency

In July, the U.S. Food and Drug Administration (FDA) announced the public release of several Complete Response Letters (CRLs) through its openFDA portal. These CRLs correspond to drug applications—both chemical and biological—submitted between 2020 and 2024. For confidentiality, the letters have been appropriately redacted.

This initiative aims to enhance transparency between applicants and the agency, reducing misunderstandings during the drug approval process. The FDA confirmed that additional CRLs will be released in the future.

CRLs are issued when a drug application cannot be approved in its current form. Common reasons include inadequate manufacturing processes, lack of demonstrated bioequivalence, or unresolved safety concerns. The CRL outlines specific deficiencies and, when applicable, includes suggestions for corrective action.

For further details, stakeholders are encouraged to review the FDA’s announcement and the released CRLs available via the openFDA platform.

23-07-2025