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# Transdermal, Topical Delivery System Guidance
- URL: https://www.fdaweb.com/transdermal-topical-delivery-system-guidance/
- Published: 2019-11-20T12:00:00.000Z
- Updated: 2026-09-14T15:53:51.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5145548

FDA has issued a draft guidance, *Transdermal and Topical Delivery Systems—Product Development and Quality Considerations*, with recommendations for applicants and manufacturers of transdermal and topical delivery systems regarding the pharmaceutical development and quality information to include in NDAs and ANDAs. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transdermal-and-topical-delivery-systems-product-development-and-quality-considerations?ref=fdaweb.com) specifically discusses the agency’s current thinking on product design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special considerations for areas where quality is closely tied to product performance and potential safety issues such as adhesion failure and the impact of applied heat on drug delivery