The Food and Drug Administration on Thursday said it would start releasing rejection letters soon after they are provided to drugmakers, a victory for those who wanted more transparency on what has been a hidden part of the drug review process.
The agency also made public 89 so-called complete response letters (or CRLs) from 2024 and 2025 that had previously not been disclosed, including letters to Replimune , Capricor Therapeutics , and Ultragenyx , which have recently received rejections under the Trump administration.
“This is a milestone day for the agency,” FDA Commissioner Marty Makary said in a statement. “By embracing radical transparency — one of the guiding principles of this administration — we’re giving invaluable insights to help speed therapies and cures to market,