FDA Releases Previously Unseen CRLs in Transparency Push

FDA Initiates Real-Time CRL Publication: What It Means for Drug Developers

The agency says it will now publish complete response letters promptly, offering developers early insight into regulatory deficiencies to improve development planning.

The FDA is getting more transparent about drug rejections

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning morning. Today, we learn the FDA is committing to CRL transparency, remember the impact of a gene therapy pioneer, and see positive LSD data for anxiety. FDA makes good on pledge on drug rejection letters The Food and Drug Administration is now publishing complete response letters to drugmakers shortly after they ar…

Dr. Makary Says FDA Will Release 89 Unpublished Decision Letters for Transparency — Announces Real-Time Disclosure of Rejections After Years of Hiding Critical Drug Data from the Public | The Gateway Pundit | by Jim Hᴏft

FDA Commissioner Dr.

FDA to publish CRLs in real time; PEPFAR to distribute Gilead’s Yeztugo

The FDA also unveiled a batch of 89 previously unpublished complete response letters, including rejection notices to Capricor and Replimune.

FDA releases previously unseen CRLs in transparency push

The FDA's earlier decision to publish complete response letters was largely a repackaging of existing information, but now it has gone much further.