> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ANDA Transdermal/Topical Delivery Systems Guide
- URL: https://www.fdaweb.com/anda-transdermal-topical-delivery-systems-guide/
- Published: 2023-04-14T12:00:00.000Z
- Updated: 2026-09-14T18:25:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154218

*Federal Register* notice: FDA is making available a revised draft guidance entitled “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.”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 the *in vivo* skin irritation and sensitization potential of a proposed generic drug transdermal or topical delivery system. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-04-13/pdf/2023-07769.pdf?ref=fdaweb.com).