FDA Contact Dermatitis From Topical Drug Products for Cutaneous Application Human Safety Assessment

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Contact Dermatitis From Topical Drug Products for Cutaneous Application Human Safety Assessment[附网盘链接]是FDA发布的FDA标准，适用于美国。

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Draft — Not for Implementation 1 Contact Dermatitis from Topical Drug Products 2 for Cutaneous Application: Human Safety Assessment 1

3 Guidance for Industry 4 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 10 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 11 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 17 I. INTRODUCTION 18 19 The purpose of this guidance is to provide FDA’s current thinking about local safety assessment 20 for the risk of contact dermatitis (irritant, allergic, and photoallergic) during development of new 2

21 drug products intended for topical application to the skin. The recommendations in this 22 guidance are informed in part by the public workshop entitled “Human Dermal (Skin) Safety 3

23 Testing for Topical Drug Products,” which FDA hosted on September 10, 2018. 24 25 This guidance does not address local safety assessment for other cutaneous adverse reactions 26 (e.g., hyperpigmentation, atrophy) for topical drug products, local safety assessment for 27 transdermal systems, evaluation of nonprescription drug ingredients to determine whether they 28 are “generally recognized as safe,” or development of generic drug products. It also does not 29 address phototoxicity (photoirritation), as this topic has been addressed in the ICH guidance for 4

30 industry S10 Photosafety Evaluation of Pharmaceuticals (January 2015). 31 32 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 33 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 34 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 1

This guidance has been prepared by the Division of Dermatology and Dental Products in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drugs include both human drugs and therapeutic biological products unless otherwise specified. 3

Check the workshop web page at https://www.fda.gov/drugs/news-events-human-drugs/human-dermal-skin-safety-

testing-topical-drug-products-regulatory-utility-and-evaluation-public. 4

We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

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