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ANDAs Must Include All Bioequivalence Data: FDA

Law360 (January 20, 2009, 12:00 AM EST) -- The U.S. Food and Drug Administration issued a final rule Tuesday requiring pharmaceutical companies that apply to sell generic medications to provide data from all the bioequivalence studies they conduct on a proposed drug, regardless of whether it supports their application or not.

Until now, abbreviated new drug applications have only had to include bioequivalence studies showing that a generic product meets the FDA's bioequivalence standards. Applicants have not had to hand over studies that, for instance, do not prove that the product satisfies the criteria,...
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