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 US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

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 ...

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The U.S. Food and Drug Administration has issued warning letters to four companies — Zest US Wholesale Inc., Xin Ao International Group Corp., Gongora USA Corp., and San Juan Produce LLC — for ...

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