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# Draft Guide on Transdermal Irritation Studies
- URL: https://www.fdaweb.com/draft-guide-on-transdermal-irritation-studies/
- Published: 2018-10-10T12:00:00.000Z
- Updated: 2026-09-15T00:37:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142554

*Federal Register* notice: FDA has made available a draft guidance entitled “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.” The document provides recommendations for the design and conduct of studies to evaluate in vivo skin irritation and sensitization potential for proposed transdermal or topical delivery systems. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-10/pdf/2018-21958.pdf?ref=fdaweb.com).