The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance ...
The US Food and Drug Administration (FDA) has just released its long-awaited Warning Letter to Sun Pharmaceuticals following a 483 and import alert announced earlier this year. And as the letter ...
The Food and Drug Administration's (FDA) drug review arm has proposed withdrawing approval for Amgen Inc.’s AMGN Tavneos (avacopan), citing concerns over data integrity, lack of proven effectiveness, ...
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