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.
CRLs may be issued for a number of reasons, including safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues. Transparency in the process is important, because entities developing drugs, as well as capital markets, want predictability when dealing with the FDA. When CRLs have been kept private in the past, sponsors have sometimes publicly misrepresented the FDA’s rationale for the denial of their application. Investors favor more clarity in order to maintain their confidence in the product pending approval, especially after learning that the product has received a rejection. To a product’s financial backers, the timing of the release of information surrounding the product application’s rejection is critical.
For example, a 2015 study conducted by the FDA found that manufacturers’ press releases regarding CRLs often left out key information, or no press release was issued following a CRL at all. Often, the information regarding the CRL in the press release did not match the FDA’s own statements on the safety and efficacy of the product.
The first batch of letters can be found here. According to the FDA, additional CRLs for previously approved drugs will be posted into a dedicated database intended to provide more insight into how the FDA makes its decisions.
