FDA, in Policy Shift, Publishes some Drug Rejection Letters

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.

FDA Opens Access to Over 200 CRLs

FDA enhances transparency by publishing over 200 Complete Response Letters, offering insights into drug approval processes and common deficiencies.

For first time ever, FDA publishes drug rejection letters

In a historic first, the FDA on Thursday released about 200 novel and generic drug rejection letters, bucking the agency's former unwillingness to release the documents. But it's a small step ...