The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (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 titled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
US Federal Register - FDA Notices · August 24, 2026
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
FDA announces availability of draft product-specific guidances on bioequivalence study design for abbreviated new drug applications.
Published by US Federal Register - FDA Notices. HealthSignal links to the original document; the summary above is extracted from the source text.