Guidance for Industry: Bioequivalence Recommendations for Specific Products

摘要

This guidance describes FDAs process for making available to the public FDA guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site,2 rather than having to request this information from the Agency and wait for the Agency to respond, as has been the case in the past. The FDA believes that making this information available on the Internet will streamline the guidance process, making it more efficient than the previous process. This process also will provide a meaningful opportunity for the public to consider and comment on BE study recommendations for specific drug products.