federal_register: 2012-1433

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-1433 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 In the Federal Register of May 31, 2007 (72 FR 30386), FDA announced the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Specific Products," explaining the process that would be used to make product-specific BE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. 2012-01-25 2012 1 https://www.federalregister.gov/documents/2012/01/25/2012-1433/draft-and-revised-draft-guidances-for-industry-describing-product-specific-bioequivalence https://www.govinfo.gov/content/pkg/FR-2012-01-25/pdf/2012-1433.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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