federal_register: 2014-07330

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2014-07330 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 June 11, 2010, FDA announced the availability of a guidance for industry entitled "Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability," which 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. 2014-04-02 2014 4 https://www.federalregister.gov/documents/2014/04/02/2014-07330/draft-and-revised-draft-guidances-for-industry-describing-product-specific-bioequivalence https://www.govinfo.gov/content/pkg/FR-2014-04-02/pdf/2014-07330.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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