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FDA publishes full texts of response letters to drug applications
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
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 related to medicines that were later approved, in a bid to improve transparency ...
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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 ...
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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 ...
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 ...