federal_register: 2016-01682

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2016-01682 Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. 2016-01-28 2016 1 https://www.federalregister.gov/documents/2016/01/28/2016-01682/product-specific-bioequivalence-recommendations-draft-and-revised-draft-guidances-for-industry https://www.govinfo.gov/content/pkg/FR-2016-01-28/pdf/2016-01682.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 additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE...

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