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Conjugated estrogens bioequivalence standards to go before FDA advisory committees July 27-28.

Executive Summary

FDA CMTE. REVIEW OF CONJUGATED ESTROGENS INGREDIENTS SET FOR JULY 27-28 will involve the Fertility & Maternal Health Drugs Advisory Committee with representatives from the Generic Drugs and Endocrine & Metabolic Drugs committees. The panel will discuss "necessary components of conjugated estrogens and other estrogens as they relate to clinical efficacy of conjugated estrogens and other estrogen replacement drug products for approved indications," FDA said. The meeting will take place at FDA's Parklawn building, conference rooms D & E, at 9 a.m. each day.
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