FDA Publishes More Than 200 Complete Response Letters

FDA Publishes More Than 200 Complete Response Letters

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

Pharmalittle: We're reading about Regeneron's patent maneuvers, FDA rejection letters, and lots more

Top of the morning to you. And a fine one it is, despite the clouds enveloping the Pharmalot campus. Birds are chirping, neighbors are mulling about, and the official mascots are scurrying across the grounds in search of creatures to annoy. As for us, we are as busy as ever hunting and gathering items of interest. We trust you have your own hectic agendas. So join us as we hoist the ever-present cup of stimulation — our choice today is maple bou…

FDA Releases 200+ Complete Response Letters to Advance Regulatory Transparency

This week, the U.S. Food and Drug Administration (FDA) published more than 200 “complete response letters” (CRLs) issued between 2020 and 2024, detailing reasons why drug or biologic applications were not approved in their current form. These letters—redacted to remove trade secrets—are now available via the openFDA portal in a move the agency dubs its “radical transparency” initiative. FDA Commissioner Marty Makary, M.D., M.P.H., emphasized the…

Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

By Sarah Wicks & Michelle L. Butler —In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database.  These particular CRLs were issued in response to original and supplemental drug and biological product applications submitted to the Agency between 2020 and 2024 that ult…