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The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...
The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to ...
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...
A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...
The U.S. FDA publishes over 200 complete response letters to enhance transparency within the agency. Read more here.
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.
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.
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 ...
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...