Technical Specifications—Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications - Guidance for Industry

Technical Specifications—Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications - Guidance for Industry

On September 10, 2018, the FDA published the guidance for industry Technical Specifications—Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications. This guidance provides recommendations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data for abbreviated new drug applications (ANDAs) should be submitted using FDA-supported data standards located in the FDA Data Standards Catalog. This guidance provides additional information related to the guidance for industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data.

By providing extensive technical details and example data tables, this guidance may help generic drug applicants to design better studies, capture critical data, and submit their results as part of a complete ANDA.