FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Offers Technical Specs and Considerations for ANDAs

Sept. 14, 2018
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The FDA issued guidance Wednesday recommending technical specifications and general considerations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data for ANDAs should be submitted using FDA-supported data standards.

All study-specific data used in generic product evaluation should be submitted using the standards listed in the FDA Data Standards Catalog, the agency said.

The guidance includes detailed specification data 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; and
  • The comparative clinical endpoint bioequivalence study that uses the endpoints: lesion count, 100 percent clearance of all actinic keratosis legions, total nasal symptom score, treatment success based on the Physician’s Global Assessment and Psoriasis Area Severity Index, intraocular pressure, and therapeutic cure based on clinical and mycological cures.

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