WASHINGTON, Dec. 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has announced the availability of additional draft and revised draft product-specific guidances for the industry. These documents offer recommendations on the design of bioequivalence (BE) studies, which are crucial components for supporting abbreviated drug applications (ANDAs) seeking approval for generic drug products.

This action follows the process outlined in a June 11, . . .

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