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.
FDA said: “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.”
The document provides the sample data tables for the Clinical Data Interchange Standards Consortium (CDISC) analysis data model (ADaM) following the Analysis Data Model Implementation Guide Version 1.1 (ADaMIG). This guidance provides detailed data specification for the following clinical studies:
- The adhesion study for transdermal delivery systems (TDS) and topical patches
- The irritation/sensitization study for TDS and topical patches
- The comparative clinical endpoint bioequivalence study using the following primary endpoints: lesion count, 100% clearance of all actinic keratosis lesions, total nasal symptom score, treatment success based on Physician’s Global Assessment and Psoriasis Area Severity Index, Intraocular pressure and therapeutic cure based on clinical and mycological cures
Technical Specifications—Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications