News Brief: FDA Releases 200 Drug Rejection Letters

Today, the U.S. Food and Drug Administration (FDA) announced that it has released over 200 Complete Response Letters (CRLs)— detailed decision documents issued when new drug or biologic applications are not approved—from applications submitted between 2020 and 2024. This marks the first batch of a broader initiative to embrace “radical transparency,” and the documents are fully redacted to remove trade secrets and confidential commercial information, according to the FDA. CRLs typically highlight common issues—safety and efficacy concerns, manufacturing deficiencies and bioequivalence problems — which sponsors have historically kept private. By opening access via openFDA, the agency aims to provide developers, investors and patients with clearer insight into FDA decision-making and avoid repeated mistakes in drug development.

FDA Commissioner Marty Makary, M.D., M.P.H. emphasized that the move is intended to end the “guessing game” that has long burdened pharmaceutical sponsors, noting that in a 2015 analysis, 85% of FDA-identified safety or efficacy concerns were omitted in public statements by companies—sometimes even when new clinical trials were recommended. The initial batch includes letters tied to previously approved applications, with more to follow as the agency systematically works through its archive. This step not only promotes accountability but also provides valuable lessons for the industry, accelerating development, improving transparency and building greater trust in FDA decisions.