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GUIDANCE DOCUMENT

Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry April 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2016-D-1254
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs” (Revision 2).  This draft guidance (Revision 2) revises the Revision 1 draft guidance of the same name, which was announced in the Federal Register on October 10, 2018.  This revised draft guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively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  The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA).

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All written comments should be identified with this document's docket number: FDA-2016-D-1254.

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