federal_register: 2016-31511

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2016-31511 Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product." This guidance is to assist the pharmaceutical industry and other investigators engaged in biosimilar product development in determining the clinical pharmacology data necessary for evaluation of a proposed biosimilar product. This guidance finalizes the draft guidance with the same name issued in May 2014. This guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). 2016-12-29 2016 12 https://www.federalregister.gov/documents/2016/12/29/2016-31511/clinical-pharmacology-data-to-support-a-demonstration-of-biosimilarity-to-a-reference-product https://www.govinfo.gov/content/pkg/FR-2016-12-29/pdf/2016-31511.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product." This guidance is to assist the...

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