In Brief: Generic bioequivalence
Executive Summary
Generic bioequivalence: FDA sent a second letter defending its bioequivalence determinations to physician organizations and state boards of pharmacy on Jan. 28. Associate Commissioner for Health Affairs Stuart Nightingale, MD, concluded that "products evaluated as therapeutically equivalent can be expected to have equivalent clinical effect whether the product is brand name or generic." A similar letter was sent in April by Deputy Center Director for Pharmaceutical Science Roger Williams, MD ("The Pink Sheet" April 28, p. 5)...
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