Zdrowie i gospodarka · 31/05/2007

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

This notice announces the availability of draft guidances for industry that describe recommendations on how to design bioequivalence (BE) studies for 200 specific drug products to support abbreviated new drug applications (ANDAs). These draft guidances are being made available concurrently with the publication of a draft guidance for industry entitled "Draft Guidance for Industry--Bioequivalence Recommendations for Specific Products" (product specific BE recommendations). This draft guidance describes the new process for making available guidance on product-specific BE studies. Under the process described in the draft guidance, draft and final product-specific BE study guidance will be made available on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a related guidance document entitled "Draft Guidance for Industry-- Bioequivalence Recommendations for Specific Products."