USA – Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

This guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this guidance relate exclusively to studies submitted in support of an abbreviated new drug application (ANDA).

In this guidance, the letter T (representing Test) will refer to proposed generic products that are the subject of an ANDA, and the letter R (representing Reference) will refer to the reference listed drug and/or reference standard product.

The recommendations relating to the design and conduct of I/S studies described in this guidance replace the recommendations related to I/S studies provided in product-specific guidances4  published before this guidance. Nonetheless, FDA recommends that applicants consult this guidance in conjunction with any relevant product-specific guidances that contain product30 specific recommendations (1) for their I/S study (such as the strength of the TDS, the duration of wear for the specific TDS, and the frequency of scoring observations) or (2) for other in vivo studies (such as adhesion or pharmacokinetics) that may be necessary to establish the bioequivalence of a proposed generic TDS drug product to its reference listed drug and/or reference standard product…