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Zdrowie i gospodarka · 8/30/2016

Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on generic risperidone injection, entitled "Bioequivalence Recommendations for Risperidone." The recommendations provide specific guidance 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 →