Zdrowie i gospodarka · 26/02/1999

Draft Guidance for Industry on Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products.'' This draft guidance provides assistance to sponsors of abbreviated new drug applications (ANDA's) by recommending study designs and scoring systems that can be used to test skin irritation and sensitization during development of transdermal products. 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. This guidance does not address the actual bioequivalence studies that would be needed for a particular transdermal drug product.