federal_register: 2015-12847

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2015-12847 Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on risperidone injection entitled "Draft Guidance on Risperidone." The recommendations provide specific guidance on the design of studies to support abbreviated new drug applications (ANDAs) for risperidone injection. This draft guidance is the second revision of a previously issued draft guidance on the same subject. 2015-05-27 2015 5 https://www.federalregister.gov/documents/2015/05/27/2015-12847/bioequivalence-recommendations-for-risperidone-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2015-05-27/pdf/2015-12847.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on risperidone injection entitled "Draft Guidance on Risperidone." The recommendations provide specific guidance on the design of studies to support...  

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