FDA publishes more than 200 rejection letters in a bid to improve transparency

The U.S. Food and Drug Administration (FDA) on Thursday published more than 200 complete response letters ((CRLs)), through which drugmakers are informed about the agency’s rejections of their products submitted for approvals.

The FDA noted that the decision to publish the initial batch of CRLs marked a significant step in its attempt to modernize and improve transparency within the agency.

“For far too long, drug developers have been playing a guessing game when navigating the FDA,” commissioner Marty Makary noted, adding, “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.”