FDA GUIDANCE · DRAFTJuly 31, 2026

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry

Status

Draft

Topic

Drug Competition Action Plan, Generic Drugs

Issue date

July 31, 2026

This is a draftguidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.