Just How Radical Is the FDA's Complete Response Letter Move?

Just how radical is the FDA's complete response letter move?

The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.

FDA publishes rejection letters sent to drugmakers, with a big caveat

FDA's Marty Makary says release of rejection letters will help drugmakers and investors understand decisions behind denials. But there's a big caveat.

FDA publishes over 200 complete response letters (MRK:NYSE)

The U.S. FDA publishes over 200 complete response letters to enhance transparency within the agency. Read more here.

FDA, in policy shift, publishes some drug rejection letters

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving medicines that it later cleared.

FDA to Share Rejection Letters Drugmakers Often Keep Secret

The head of the US Food and Drug Administration said the agency will start publishing the rejection letters that companies until now have mostly kept hidden from investors and the public.

POLITICO Pro: FDA releases tranche of complete response letters

The move comes after industry and media sought more transparency around the correspondence.