Regulatory Blog

As generic transdermal and topical delivery systems (TDS) continue to evolve, demonstrating bioequivalence extends beyond pharmacokinetic performance. Product adhesion, skin irritation, and sensitization are critical attributes that influence drug delivery, patient safety, treatment adherence, and overall therapeutic performance. To support the development of high-quality generic transdermal and topical products, the U.S. Food and Drug Administration (FDA) has issued two comp

This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical...