FDA Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids
标准简介
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids[附网盘链接]是于之前发布的FDA标准，适用于美国。标准截图
![Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids[附网盘链接]](/img/20210914103721jqa45.jpg)
标准文档说明
标准文档类型为Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids[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
Draft — Not for Implementation 1 Development of Locally Applied Corticosteroid Products for the 2 Short-Term Treatment of Symptoms Associated with Internal or 1
3 External Hemorrhoids 4 Guidance for Industry 5 6 7 8 9 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 10 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 11 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 12 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 13 for this guidance as listed on the title page. 14 15 16 17 18 I. INTRODUCTION 19 20 The purpose of this guidance is to assist sponsors in the clinical development of locally applied 21 corticosteroid products (including suppositories or products that require an applicator) for the 22 short-term treatment of symptoms associated with internal or external hemorrhoids. Specifically, 23 this guidance describes FDA’s current thinking regarding the recommended attributes of patients 2
24 for enrollment, efficacy assessments, and safety assessments. 25 26 This guidance does not address the clinical development of drugs for the chronic treatment of 27 signs and symptoms associated with internal or external hemorrhoids or drugs for the treatment 28 of an underlying disease. 29 30 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 31 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 32 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 33 the word should in Agency guidances means that something is suggested or recommended, but 34 not required. 35 36 1
This guidance has been prepared by the Division of Gastroenterology and Inborn Error Products (Division) in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2
In addition to consulting guidances, sponsors are encouraged to contact the Division to discuss specific issues that arise during the development of products.
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