HHS pushes FDA to formalize public release of rejection letters to drug makers

HHS announced it is preparing a new FDA regulation that would codify the agency's practice of publishing complete response letters (CRLs) that inform pharmaceutical companies of a drug's rejection.

The proposed rule aims to increase transparency for the industry and the public by setting clear standards for how and when these letters are released.

The administration's move comes amid broader efforts to make the drug approval process more open, though the FDA has temporarily paused work on the rule while it reviews details.