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# Clarifications Sought in Transdermal, Topical Draft Guidance
- URL: https://www.fdaweb.com/clarifications-sought-in-transdermal-topical-draft-guidance/
- Published: 2020-03-03T12:00:00.000Z
- Updated: 2026-09-14T16:05:28.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5146228

Teva says it is generally pleased with an FDA draft guidance on product development and quality considerations for transdermal and topical delivery systems but believes there are some technical issues that require further clarification. The company’s comment [letter](https://www.regulations.gov/document?D=FDA-2019-D-4447-0015&ref=fdaweb.com) raises several line-by-line technical issues for clarification.

Mylan [says](https://www.regulations.gov/document?D=FDA-2019-D-4447-0016&ref=fdaweb.com) it applauds FDA’s growing interest in exploring the adhesion scoring scale adopted by the European Medicines Agency. The company says that some of the guidance recommendations are at odds with previously issued guidance and long-standing agency practice. It lists several technical comments “to help ensure that recommendations for the development of these important products are clear and consistent.”