FDA Revises Equivalence Criteria For Generic Drug Approval

Law360, New York (December 4, 2013, 5:10 PM EST) -- The U.S. Food and Drug Administration on Wednesday revised its recommendations for how generic-drug makers can prove that their products are released into the human body in the same manner as brand-name counterparts, issuing high-level guidance covering an array of approaches.

In its draft guidance, the FDA spelled out general study characteristics to determine so-called bioequivalence. That refers to how fast and how much of an active ingredient shows up at the area of a person’s body where it’s intended to work.

Separate guidance is coming...
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