# 2026-15613: FDA decrees how sticky drug patches must cling

2026-15613, Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-08-03, effective 2026-08-03; PRIA reads it as touching household money (as of 2026-08-10).

- Canonical: https://policyrisk.com/federal-register/2026-15613
- As of: 2026-08-10
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-15613
- Title: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 48879
- Published: 2026-08-03
- Effective: 2026-08-03
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-10

## In one line

FDA decrees how sticky drug patches must cling

## Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs." This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The guidance replaces the draft guidance (Revision 2) "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs," issued on April 13, 2023.

## Effects PRIA read

- Final FDA guidance for TDS adhesion: benefit, low. The FDA published a final guidance titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs" on August 3, 2026. The guidance gives recommendations on how to design and run studies that evaluate how well transdermal or topical delivery systems stick to the skin for applicat…
- Option: Adhesion-only or combined studies: benefit, low. FDA states that applicants may choose to evaluate TDS adhesion in studies performed only to assess adhesion, or in studies that combine adhesion assessment with bioequivalence (BE) testing using pharmacokinetic (PK) endpoints. These recommendations apply to studies submitted in support of an ANDA.
- Consult product guidances; contact FDA for alternatives: benefit, low. FDA recommends that applicants consult this guidance together with any relevant product-specific guidances when planning studies, and that applicants who want to use an alternative approach contact the Agency to discuss the proposed alternative. The guidance finalizes Revision 2 (issued April 13, 2…

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## Sources
- [2026-15613 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/03/2026-15613/assessing-adhesion-with-transdermal-and-topical-delivery-systems-for-andas-guidance-for-industry)
- [2026-15613 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-03/pdf/2026-15613.pdf)

## Related
- [Previous: 2026-15612, Assessing the Irritation and Sensitization Potential of Transdermal and Topical…](https://policyrisk.com/federal-register/2026-15612)
- [Next: 2026-15615, In the Matter of Nasdaq PHLX LLC; Order Granting Petition for Review and Schedu…](https://policyrisk.com/federal-register/2026-15615)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-15613 (as of 2026-08-10).