Health Law Informer

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug applications (NDAs) or biologics license applications (BLAs) to the FDA for new drug or biological products. The FDA issues a CRL when it is rejecting a NDA or BLA on the grounds that the product in question that fails to meet statutory or regulatory standards. The CRLs published were mostly issued between 2020 and 2024, however, all products ultimately received approval after the recipient companies corrected the cited deficiencies. Of the 200 letters, many were already publicly available in the FDA’s Drugs@FDA database.