FDA Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy
标准简介
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy[附网盘链接]是于当前发布的FDA标准，适用于U.S。标准截图
![Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy[附网盘链接]](/img/202109141037422ayoh.jpg)
标准文档说明
标准文档类型为Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy[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Draft — Not for Implementation 1 Establishing Effectiveness and Safety for 2 Hormonal Drug Products Intended to 1
3 Prevent Pregnancy 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 15 I. INTRODUCTION 16 17 This guidance provides recommendations for clinical trials designed to establish clinical 2
18 effectiveness and safety for hormonal drug products intended to prevent pregnancy . Drug 19 product development in hormonal contraception has evolved over the years, especially with 20 the development of lower-dose hormonal drug products and longer-acting reversible 21 contraceptives. Changes in patient demographics, pregnancy testing, determinations of 22 conception date, and dosing directions have also occurred. This guidance reflects these 23 developments and is generally consistent with advice we have been providing to individual 24 sponsors developing hormonal drug products. 25 26 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 27 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed 28 only as recommendations, unless specific regulatory or statutory requirements are cited. The 29 use of the word should in Agency guidances means that something is suggested or 30 recommended, but not required. 31 32 33 II. CLINICAL TRIAL DESIGN FEATURES—KEY CONSIDERATIONS 34 35 A. Recommended Enrollment Criteria 36 37 Nonpregnant, premenopausal women who meet the following criteria are eligible for enrollment: 38 1
This guidance has been prepared by the Division of Bone, Reproductive, and Urologic Products in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2
This guidance does not provide development information on nonhormonal contraception or emergency contraception.
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