federal_register: 2013-20696

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2013-20696 Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Draft Guidance on Risperidone."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. 2013-08-26 2013 8 https://www.federalregister.gov/documents/2013/08/26/2013-20696/draft-guidance-for-industry-on-bioequivalence-recommendations-for-risperidone-injection-availability https://www.govinfo.gov/content/pkg/FR-2013-08-26/pdf/2013-20696.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Draft Guidance on Risperidone."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...

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