FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products

The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines.

One guidance, finalized, provides recommendations for evaluating the performance of adhesives used in these delivery systems. The other is a draft guidance that outlines how to conduct in vivo studies to assess skin irritation and sensitization potential.

These documents aim to clarify regulatory expectations and support the development of safe and effective transdermal products.