Embracing Transparency, FDA Will Make All Future Drug Rejection Letters Public

Embracing Transparency, FDA Will Make All Future Drug Rejection Letters Public

FDA Commissioner Marty Makary said publishing complete response letters recognizes public interest in the transparency and credibility of agency decision-making about drugs. He also said the move complies with an executive order that covers the communication of scientific data. The post Embracing Transparency, FDA Will Make All Future Drug Rejection Letters Public appeared first on MedCity News.

In major shift, FDA to start releasing rejection letters shortly after they're issued

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 of these complete response letters from 2024 and 2025 that had previously not been disclosed, including letters to Replimune, Capricor Therapeutics, and Ultragenyx, which ha…

Radical Transparency, Act II: FDA Releases 89 Previously Unpublished Complete Response Letters

By Sarah Wicks & Michelle L. Butler —Yesterday, FDA announced the publication of 89 previously unpublished Complete Response Letters (“CRLs”), which appears to be the next step in FDA’s effort towards “radical transparency.” The first step was the posting of 200 already-published CRLs on July 10, 2025, which we blogged about here. However, this latest development marks a significant change in Agency policy as the CRLs released yesterday are CRLs…

In a first, FDA publishes complete response letters for ongoing drug applications

On Thursday, the FDA finally did what several prior agency commissioners only promised to do: publish redacted complete response letters for drugs that are still under consideration by the agency despite the initial rejection. ...