News

FDA Will Share Rejection Letters Drugmakers Often Conceal
The US Food and Drug Administration is starting to publish letters the agency sent to pharmaceutical companies when their ...
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 Biotech15h
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. | ...
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 ...
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.
BioSpace14h
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
Indianapolis Business Journal14h
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.
STAT17h
Pharmalittle: We’re reading about Regeneron’s patent maneuvers, FDA rejection letters, and lots more
A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...
FierceBiotech1mon
Stealth hit by FDA rejection to twice-delayed filing
Stealth BioTherapeutics’ 16.5-month priority review cycle has ended in rejection. After delays, Stealth said the FDA turned down its request ... soon received a refusal-to-file letter from the FDA.
CNN11mon
FDA rejection of MDMA-assisted therapy rattles advocates but ... - CNN
FDA rejection of MDMA-assisted therapy rattles advocates but doesn’t spell end of psychedelics in medicine, experts say By Deidre McPhillips and Carma Hassan , CNN 8 minute read ...