FDA Atopic Dermatitis Timing of Pediatric Studies During Development of Systemic Drugs
标准简介
Atopic Dermatitis Timing of Pediatric Studies During Development of Systemic Drugs[附网盘链接]由FDA于过去发布，适用于US。标准截图
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标准文档说明
标准文档类型为Atopic Dermatitis Timing of Pediatric Studies During Development of Systemic Drugs[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs 1
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION AND BACKGROUND This guidance addresses FDA’s current thinking about the relevant age groups to study and how early in drug development applicants should incorporate pediatric patients for development of systemic drugs for atopic dermatitis (AD). The recommendations in this guidance are based on input received from the March 9, 2015, Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) meeting on this topic and review of medical literature and relevant statutes and regulations. This guidance does not address the technical aspects of drug development for pediatric patients 2
with AD, which FDA will address in a future guidance. AD is a chronic pruritic inflammatory skin disease that primarily affects pediatric patients but also occurs in adults. AD is associated with substantial morbidity, including sleep disruption, decreased neurocognitive function, and impaired quality of life for patients and their families. AD is also associated with numerous comorbidities, including cutaneous infections, extracutaneous infections, asthma, rhinitis, food allergies, obesity, and hypertension. Historically, FDA recommended that applicants provide data on the use of topical drug products in pediatric patients for treatment of AD before initial drug approval. In contrast, FDA did not recommend initiation of pediatric studies for systemic drugs under development for treatment of 1
This guidance has been prepared by the Division of Dermatology and Dental Products in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2
Currently available is the draft guidance for industry General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products. When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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