PV Bulletin

FDA Final Guidance on Assessing Adhesion for ANDAs

The FDA has released final guidance on assessing adhesion for transdermal and topical delivery systems in support of abbreviated new drug applications (ANDAs). This guidance outlines expectations for study designs and reporting requirements related to adhesion performance.

Primary source: Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft Gu

PV Impact Brief

Urgency: HighConfidence: high

What changed

The final guidance provides specific instructions regarding study design, scoring systems, and data analysis to assess adhesion performance in transdermal and topical delivery systems, which replaces previous draft guidance from April 2023.

Why it matters

Adhesion failures can lead to improper dosing or accidental exposure, impacting patient safety. This guidance ensures that generic products meet specific safety standards and maintain proper functionality throughout their wear period.

Action needed

Manufacturers and applicants must utilize the finalized scoring system for new study submissions and ensure post-market safety reports include monitoring for adhesion-related issues as indicators of product quality.

Relevant for
Regulatory Intelligence LeadSignal Management LeadQPPV
Processes impacted
Signal ManagementCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Guideline
Policy status
final
Publication date
2026-08-03
Policy change
This final guidance outlines the clinical expectations for assessing the adhesion of transdermal and topical delivery systems (TDS) in support of an ANDA. It finalizes a draft from 2024 and provides clear instructions on study design, scoring systems, and data analysis to ensure that generic products perform as expected and maintain safety throughout their wear period. Adhesion failures are a safety concern as they can lead to improper dosing or accidental exposure.

Key changes

Standardized adhesion scoring system, expectations for study duration, and requirements for analyzing and reporting adhesion data to demonstrate similarity to the reference product.

Affected workflows

Signal ManagementCountry Compliance

Responsible groups

MAHsClinical SafetyRegulatory Affairs

Document identifiers

FDA-2024-D-2131

PV impact

MAHs should ensure that post-market safety surveillance and signal management processes include monitoring for adhesion-related reports, as these can be indicators of product quality issues or safety risks (e.g. unintended exposure to others). Clinical teams must use the finalized scoring system for new study submissions.

View regulator source

Source document details

Exact policy details

Guidance Availability Date
August 3, 2026
Applies to: Guidance for industry on assessing adhesion with transdermal and topical delivery systems for ANDAs
Published in the Federal Register · p. 1 · High · Source
Docket Number
FDA-2016-D-1254
Applies to: Docket reference for comments and guidance queries
Document heading · p. 1 · High · Source
Replacement of Prior Guidance
Replaces draft guidance issued on April 13, 2023
Applies to: Applies to industry conducting studies for ANDA submissions
In the announcement summary · p. 1 · High · Source

Workflow rule impacts

ANDAs SubmissionFDA Regulatory Affairs

Requires applicants to design studies according to new standards for adhesion performance

New guidance on evaluating TDS adhesion

Guidance provides recommendations for study design · p. 1 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Aug 3, 2026

Full briefing

Practical implication

Manufacturers and applicants must utilize the finalized scoring system for new study submissions and ensure post-market safety reports include monitoring for adhesion-related issues as indicators of product quality.

This final guidance outlines clinical expectations for assessing the adhesion of transdermal and topical delivery systems (TDS) in support of ANDAs, emphasizing a standardized scoring system and monitoring for adhesion-related reports.

What changed: The final guidance provides specific instructions regarding study design, scoring systems, and data analysis to assess adhesion performance in transdermal and topical delivery systems, which replaces previous draft guidance from April 2023.

Why it matters: Adhesion failures can lead to improper dosing or accidental exposure, impacting patient safety. This guidance ensures that generic products meet specific safety standards and maintain proper functionality throughout their wear period.

Practical implication: Manufacturers and applicants must utilize the finalized scoring system for new study submissions and ensure post-market safety reports include monitoring for adhesion-related issues as indicators of product quality.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#Guideline#final#Reporting Requirement#policy-change#firecrawl-policy-agent#Food and Drug Administration

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