F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs

July 11, 2025

picture of the U.S. Food and Drug Administration sign

(New York Times) – The Food and Drug Administration on Thursday published a database containing more than 200 letters to pharmaceutical companies detailing why the agency initially refused to approve their products, shedding light on an obscure and contentious aspect of drug development.

F.D.A. officials described the move as a form of “radical transparency.” But many of the documents were already available on the agency website, albeit often difficult to find and typically posted weeks after a drug’s approval. (Read More)