News

FDA Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
US FDA publishes 200 rejection letters in transparency push
The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to ...
Fierce Biotech22h
FDA releases ‘initial batch’ of more than 200 drug rejection letters
The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...
F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
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.
STAT16h
FDA publishes rejection letters sent to drugmakers, with a big caveat
The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.
Indianapolis Business Journal21h
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.
BioSpace2h
FDA’s Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
BioPharma Dive21h
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 ...
Milestone says heart disorder therapy under FDA review again
Milestone Pharmaceuticals (MIST) stock falls amid a capital raise as FDA agrees to review its resubmitted NDA for heart therapy Cardamyst. Read more here.
FDA Publishing Complete Response Letters to Boost Transparency
The FDA on Thursday said it published more than 200 decision letters, known as complete response letters, that it issued in response to applications for approval of drugs or biological products ...