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Zdrowie i gospodarka · 22/09/2014

FDA Releases Revised Draft Guidance for Estradiol Vaginal Cream Bioequivalence Studies

The Food and Drug Administration (FDA) has released a revised draft guidance for industry on estradiol vaginal cream, providing recommendations for bioequivalence studies to support abbreviated new drug applications (ANDAs).

Source: Federal Register — Food and Drug AdministrationOpen original release →