federal_register: 2013-29080

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2013-29080 Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Bioequivalence Recommendations for Paliperidone Palmitate." The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release injectable suspension. 2013-12-05 2013 12 https://www.federalregister.gov/documents/2013/12/05/2013-29080/draft-guidance-for-industry-on-bioequivalence-recommendations-for-paliperidone-palmitate https://www.govinfo.gov/content/pkg/FR-2013-12-05/pdf/2013-29080.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Bioequivalence Recommendations for Paliperidone Palmitate." The guidance provides specific recommendations on the design of...

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