FDA pauses public release of Complete Response Letters to limit litigation risk

The FDA announced it has temporarily halted the routine public posting of Complete Response Letters (CRLs), which are letters sent to drug sponsors when the agency does not approve a marketing application.

Agency officials said the pause is intended to reduce the risk of lawsuits that can arise from the disclosure of sensitive commercial information contained in the letters.

The decision follows a legal challenge raised by a law firm in April, prompting the regulator to reassess its policy on CRL transparency.