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Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Draft Guidance for Industry; Availability

🏛 Food and Drug Administration (FDA)FDA-2018-D-3546

Pharmaceutical Policy

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4

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0

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Open

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Rules, notices, and supporting material — the primary rule pinned first.

All 4 Other 3 Notice 1

📄 Primary document

OtherAug 3, 2026

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Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Guidance for Industry; Draft Guidance

Open · 60 days left

Notice· Aug 3, 2026
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability→
Open · 60 days left
Other· Apr 13, 2023
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability→
Closed on Jun 13, 2023
Other· Oct 10, 2018
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry DRAFT GUIDANCE→
Closed on Dec 11, 2018