The FDA is publishing a final guidance and a revised draft guidance for studies supporting abbreviated new drug applications for transdermal and topical delivery systems. The new guidance on adhesion finalizes the agency’s April 2023 draft and gives applicants recommendations for designing and conducting studies to evaluate how well a transdermal or topical delivery system sticks to the skin.
The FDA said applicants may assess adhesion in dedicated adhesion studies or in combined studies that also evaluate bioequivalence with pharmacokinetic endpoints, depending on their development goals. The agency also said applicants should consult the guidance alongside any product-specific guidance and should contact FDA if they want to use an alternative approach.
As part of the Drug Competition Action Plan, FDA said the final guidance is intended to increase competition, facilitate entry of high-quality and affordable generic drugs, and improve public health. The agency said clearer recommendations should reduce duplicative work, regulatory delays, and uncertainty for industry, while also helping FDA streamline application review.
FDA is also publishing a revised draft guidance on irritation and sensitization potential for transdermal and topical delivery systems. That draft provides recommendations for in vivo skin irritation studies, and, when applicable, combined skin irritation and sensitization studies submitted in support of ANDAs. It replaces the April 2023 draft of the same name.[
The agency said the updated recommendations are meant to clarify its expectations and further reduce duplicative efforts, delays and review time for these products. FDA said the changes should help speed approval of generic products, giving the public more treatment options and potential cost savings.
FDA guidance announcement and linked documents: Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry | FDA and Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs | FDA.
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