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 ...
Fierce Biotech8d
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. | ...
STAT7d
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 ...
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.
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters ...
Indianapolis Business Journal8d
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.
STAT8d
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 ...