Dermal pharmacology: challenges facing generic topical and transdermal drug development

21 January 2025

By Dr Nicola Davies

This article explores the latest conversations around generic topical and transdermal drug delivery systems (TDS) in the US Food and Drug Administration’s (FDA dermal pharmacology space, delving into recent guidance updates and examining the challenges facing the development of generic TDS.

TDS is a form of drug administration designed to deliver therapeutics through a patient’s skin, providing some significant benefits compared to other dosage forms. TDS can be engineered to provide continuous drug delivery over longer time intervals, which would maintain continuous efficacy of the drug and reduce frequency of administration.

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