FDA Temporarily Suspends CRL Publication Policy

The U.S. Food and Drug Administration (FDA) has temporarily halted its policy of publicly releasing complete response letters (CRLs) that detail reasons for new‑drug approval denials. The suspension follows an anonymous pharmaceutical company’s citizen petition filed in April, prompting the agency to pause the practice. The CRL‑publication policy was introduced in September of the previous year as part of the FDA’s “radical transparency” initiative, which pledged real‑time disclosure of CRLs when drug approval or rejection decisions are made. The move was announced under Health Secretary Robert F. Kennedy Jr. A spokesperson for the U.S. Department of Health and Human Services (HHS) said the agency is currently evaluating the procedures and potential next steps regarding the CRL disclosure policy.