Federal Register #FDA-2018-D-3546

FDA Issues Revised Draft Guidance on Irritation and Sensitization Studies for Transdermal and Topical Drug Delivery Systems

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, announces the release of a revised draft guidance for industry regarding transdermal and topical drug delivery systems (TDS) for ANDAs. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are mentioned in this notice - Products/Services Requested: - No products or services are being requested - The notice provides guidance for industry on evaluating irritation and sensitization potential of TDS in support of abbreviated new drug applications (ANDAs) - Notable Requirements: - The guidance outlines recommendations for designing and conducting in vivo studies for skin irritation and sensitization - Clarifies when sensitization studies may not be necessary - Seeks industry comments on the guidance, including alternative approaches and scoring scales - Replaces previous draft guidance from April 2023 - No purchase quantities, part numbers, or procurement actions are included in this notice

Description

The Food and Drug Administration (FDA) has released a revised draft guidance for industry on assessing the irritation and sensitization potential of transdermal and topical delivery systems (TDS) for abbreviated new drug applications (ANDAs). This guidance provides recommendations for designing and conducting in vivo studies to evaluate skin irritation and sensitization potential of proposed TDS products. It clarifies FDA's expectations and replaces the previous draft guidance from April 2023. The guidance aims to ensure safety and efficacy of TDS products by recommending comparative assessments of test and reference products.

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