FDA Acne Vulgaris Establishing Effectiveness of Drugs Intended for Treatment
标准简介
Acne Vulgaris Establishing Effectiveness of Drugs Intended for Treatment[附网盘链接]是于过去发布的FDA标准，适用于US。标准截图
![Acne Vulgaris Establishing Effectiveness of Drugs Intended for Treatment[附网盘链接]](/img/20210914103548z5n15.jpg)
标准文档说明
标准文档类型为Acne Vulgaris Establishing Effectiveness of Drugs Intended for Treatment[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
Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment 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 The purpose of this guidance is to provide recommendations to industry for establishing clinical 2
effectiveness of drugs for the treatment of acne vulgaris (acne). The recommendations in this guidance are based on the FDA’s assessment of issues raised in the review of clinical trials for acne. This guidance does not address systemic retinoid therapies because they may not have appropriate risk-benefit profiles for non-nodular acne therapy. Sponsors should discuss development programs for systemic retinoids with the review division before trial initiation. This guidance also does not address clinical safety, clinical pharmacokinetics, nonclinical issues, or chemistry, manufacturing, and controls issues. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. BACKGROUND Acne is a chronic disease of sebaceous follicles that is multifactorial in etiology. It can wax and wane in severity according to lesion types, numbers, and extent of involvement and can result in 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 human drugs and not therapeutic biological products unless otherwise specified.
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