USA – ANDA Technical Specifications: FDA Guidance

The US Food and Drug Administration on Wednesday offered new 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.

The guidance is intended to complement interactions between applicants and FDA review divisions, though it is not intended to replace direct communications regarding approaches or issues relating to data standards…