FDA Updates Active Ingredient Guidance For New Drug Studies

Law360, New York (March 17, 2014, 5:11 PM EDT) -- The U.S. Food and Drug Administration on Monday released important guidance on the testing of new prescription drugs before and after approval, explaining its current thinking on how manufacturers can show the way their active ingredients work in the human body.

In its 29-page draft guidance, the FDA described the required content of studies that demonstrate so-called bioavailability, which refers to how quickly and comprehensively key molecules show up at a certain part of the body and exert their effects. Also covered was so-called bioequivalence, which...
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