This article was originally published in The Tan Sheet
FDA "Draft Guidance for Industry on Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products" available at www.fda.gov/cder/guidance/index.htm. The document "provides assistance to sponsors of abbreviated new drug applications...by recommending study designs and scoring systems that can be used to test skin irritation and sensitization during development of transdermal products," FDA says. "To fully evaluate the equivalence of a transdermal product to a reference listed drug, skin irritation and sensitization should be assessed because skin conditions may affect the efficacy or safety of the product," the agency adds
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