FDA drafts rules for rash-inducing patch perfection
Published Date: 8/3/2026
Notice
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a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 The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization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 This draft guidance replaces the draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs" (April 2023).
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA draft guidance for TDS studies
FDA published a revised draft guidance titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs" that provides recommendations for the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 transdermal or topical delivery systems submitted with an ANDA. This revised draft replaces the April 2023 draft and the Agency is accepting comments on it through October 2, 2026.
Clarifies when sensitization tests unnecessary
The revised draft guidance clarifies circumstances when an in vivo sensitization study for a transdermal or topical delivery system may not be needed for an ANDA submission.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 through October 2, 2026.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-19181, Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The FDA just dropped a draft guide to help medical device makers submit their big approval applications electronically. This new template aims to make submissions easier, faster, and more consistent for companies working with the FDA’s device and biologics centers. If you’re in the medical device game, check it out and send your feedback by November 17, 2026—no fees or changes yet, just a heads-up for smoother future filings!
2026-19141, Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability
The FDA just released a draft guide to help vets and companies test the safety of special animal medicines called veterinary monoclonal antibodies. This new guide aims to make safety testing easier and more consistent worldwide, helping get these medicines to animals faster and safer. If you’re involved in making or testing these products, send your feedback by November 17, 2026, to shape the final rules!
2026-19166, Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document
The FDA just shared a draft plan to help make interchangeable biosimilar drugs easier to develop and approve. This affects drug makers and patients who want more affordable medicine options. The FDA wants your feedback by November 17, 2026, before finalizing the plan, which supports innovation and smoother drug approvals through 2027.
Previous / Next Documents
Previous: 2026-15611, Agency Information Collection Activities
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the U.S. Election Assistance Commission (EAC) gives notice that it is requesting from the Office of Management and Budget (OMB) an extension of the previously approved information collection OMB Control Number 3265-0026 EAC Progress Report (EAC-PR).
Next: 2026-15613, Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Availability
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.