Zdrowie i gospodarka · 2.11.2015
Bioequivalence Recommendations for Progesterone; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on progesterone gel entitled "Draft Guidance on Progesterone." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for progesterone gel.