federal_register: E9-28593

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-28593 Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Notice The Food and Drug Administration (FDA) 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 In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Specific Products," explaining the process that would be used to make product- specific BE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. 2009-12-01 2009 12 https://www.federalregister.gov/documents/2009/12/01/E9-28593/draft-and-revised-draft-guidances-for-industry-describing-product-specific-bioequivalence https://www.govinfo.gov/content/pkg/FR-2009-12-01/pdf/E9-28593.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) 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...

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