The Food and Drug Administration has announced the availability of a draft guidance for industry entitled “Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products”. This document is intended to assist applicants by recommending study designs and scoring systems that can be used to test skin irritation and sensitization during development of transdermal products in order to ensure the safety of the product. However, the guidance does not address the actual bioequivalence studies that would be needed for a particular transdermal drug product.

Copies of the draft guidance are available from the Drug Information Branch, (HFD- 210), Center for Drug Evaluation & Research (CDER), 5600 Fishers Lane, Rockville MD 20857, USA (with one self-addressed adhesive label) or from the Internet at: http://www.fda.gov/cder/guidance/index.htm.

Reference: Federal Register 64(38): 9516 (1999).