News

BioPharma Dive40m
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 ...
Fierce Biotech1h
FDA releases ‘initial batch’ of more than 200 drug rejection letters
The FDA has released an "initial batch" of 200 complete response letters (CRLs) in efforts to boost transparency. | The FDA has released an "initial batch" of 200 complete response letters (CRLs) in ...
Indianapolis Business Journal31m
FDA begins sharing rejection letters drugmakers often kept secret
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.
FDA publishes more than 200 rejection letters in a bid to improve transparency
The U.S. FDA publishes over 200 complete response letters to enhance transparency within the agency. Read more here.