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FDA CHANGES IN BIOEQUIVALENCE STANDARDS SHOULD BE MADE ONLY AFTER HEARING, GPIA SUGGESTS; LEGISLATIVE CHANGES SHOULD FORESTALL PREMARIN-STYLE DEBATES

Executive Summary

Changes in established bioequivalence standards, including bioguidances, should be made only after a hearing, "and only then if the change is shown to be necessary to establish the safety and efficacy of the product," the Generic Pharmaceutical Industry Association states in its FDA reform proposal forwarded to the House and Senate Oct. 5.
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