FDA Dry Eye Developing Drugs for Treatment Guidance for Industry
标准简介
Dry Eye Developing Drugs for Treatment Guidance for Industry[附网盘链接]是FDA发布的FDA标准，适用于U.S。标准截图
![Dry Eye Developing Drugs for Treatment Guidance for Industry[附网盘链接]](/img/20210914103731wu4qm.jpg)
标准文档说明
标准文档类型为Dry Eye Developing Drugs for Treatment Guidance for Industry[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Draft — Not for Implementation 1 Dry Eye: Developing Drugs 2 for Treatment 1
3 Guidance for Industry 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic.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 is intended to provide recommendations to sponsors regarding eligibility criteria, 18 trial design considerations, and efficacy endpoints to enhance clinical trial data quality and to 2
19 foster greater efficiency in development programs for drugs for the treatment of dry eye. 20 21 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 22 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 23 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 24 the word should in Agency guidances means that something is suggested or recommended, but 25 not required. 26 27 28 II. CONSIDERATIONS FOR CLINICAL TRIALS 29 30 A. Trial Design 31 32 Sponsors developing drugs for the treatment of dry eye should consider the following regarding 33 trial design: 34 35 • Both traditional environmental exposure trials and challenge-model trials (utilizing a 36 controlled chamber with regulated temperature, air flow, humidity, etc.) can be acceptable. 37 1
This guidance has been prepared by the Division of Ophthalmology in the Center for Drug Evaluation and Research at the Food and Drug Administration. For biological products regulated by the Center for Biologics Evaluation and Research, sponsors should contact the Office of Tissues and Advanced Therapies. 2
For the purposes of this guidance, all references to drugs include both human drugs and therapeutic biological products unless otherwise specified.
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