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Zdrowie i gospodarka · 8/26/2013

Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Draft Guidance on Risperidone." The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for risperidone injection.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →