WASHINGTON, D.C. (WDNews) –
In a sweeping move toward transparency, the U.S. Food and Drug Administration (FDA) has published more than 200 complete response letters (CRLs) between 2020 and 2024.
CRLs are formal documents explaining why certain drugs or biological products were not approved.
This marks the first time the FDA has publicly released such a broad set of CRLs, which detail common deficiencies like safety concerns, manufacturing issues and bioequivalence problems. Previously, these letters were sent only to product sponsors and kept confidential.
“For far too long, drug developers have been playing a guessing game when navigating the FDA,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”
A 2015 FDA study found that sponsors often withheld critical details when publicly disclosing drug denials. For instance, 85% of safety and efficacy concerns mentioned in CRLs were left out of sponsor announcements, and new clinical trial requirements were disclosed only 60% of the time.
By making these letters public, the FDA hopes to prevent repeated mistakes in drug development and provide more clarity for investors, researchers, and patients. The initial batch of redacted CRLs—tied to now-approved applications—is available on the openFDA platform.
More letters from past and ongoing reviews are expected to be added in the coming months.
