# 2026-15612: FDA drafts rules for rash-inducing patch perfection

2026-15612, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-08-03, effective Submit either electronic or written comments on the draft guidance by October 2, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.; PRIA reads it as touching household money (as of 2026-08-10).

- Canonical: https://policyrisk.com/federal-register/2026-15612
- As of: 2026-08-10
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-15612
- Title: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 48882
- Published: 2026-08-03
- Effective: Submit either electronic or written comments on the draft guidance by October 2, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Comments close: 2026-10-02
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-10

## In one line

FDA drafts rules for rash-inducing patch perfection

## Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization studies. This draft guidance replaces the draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs" (April 2023).

## Effects PRIA read

- FDA draft guidance for TDS studies: benefit, medium. FDA published a revised draft guidance titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs" that provides recommendations for the design and conduct of in vivo skin irritation and combined irritation/sensitization studies for transderma…
- Clarifies when sensitization tests unnecessary: benefit, medium. The revised draft guidance clarifies circumstances when an in vivo sensitization study for a transdermal or topical delivery system may not be needed for an ANDA submission. FDA requests comments on this point (and on scoring scales and comparative assessment methods) and is accepting comments thro…

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## Sources
- [2026-15612 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/03/2026-15612/assessing-the-irritation-and-sensitization-potential-of-transdermal-and-topical-delivery-systems-for)
- [2026-15612 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-03/pdf/2026-15612.pdf)

## Related
- [Previous: 2026-15611, Agency Information Collection Activities](https://policyrisk.com/federal-register/2026-15611)
- [Next: 2026-15613, Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Gui…](https://policyrisk.com/federal-register/2026-15613)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-15612 (as of 2026-08-10).