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Zdrowie i gospodarka · 1.12.2009

Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability

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 In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Specific Products," explaining the process that would be used to make product- specific BE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.

Source: Federal Register — Food and Drug AdministrationOpen original release →