FDA Chemotherapy-Induced Nausea and Vomiting Developing Drugs for Prevention Guidance for Industry Draft
标准简介
Chemotherapy-Induced Nausea and Vomiting Developing Drugs for Prevention Guidance for Industry Draft[附网盘链接]由FDA于不久之前发布，适用于U.S。标准截图
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标准文档说明
标准文档类型为Chemotherapy-Induced Nausea and Vomiting Developing Drugs for Prevention Guidance for Industry Draft[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Draft — Not for Implementation 1 Chemotherapy-Induced Nausea and Vomiting: 2 Developing Drugs for Prevention 1
3 Guidance for Industry 4 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 10 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 11 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 17 I. INTRODUCTION 18 19 The purpose of this guidance is to help sponsors in the clinical development of drugs for the 2
20 prevention of chemotherapy-induced nausea and vomiting (CINV) in adults. Specifically, this 21 guidance addresses FDA’s current recommendations on clinical trials for drugs being developed 22 under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355) and 21 CFR 23 Parts 312 and 314 for the prevention of CINV and considerations for eligibility criteria, trial 3
24 design features, efficacy evaluations, and clinical outcome assessments. 25 26 This guidance does not address the development of drugs for the treatment of CINV or the 27 prevention or treatment of nausea and vomiting unrelated to the administration of 4
28 chemotherapeutic agents. 29 30 The contents of this document do not have the force and effect of law and are not meant to bind 31 the public in any way, unless specifically incorporated into a contract. This document is 32 intended only to provide clarity to the public regarding existing requirements under the law. 1
This guida nce has been prepared by the Division of Gastroenterology in the Center for Drug Evaluation a nd Resea rch at the Food a nd Drug Administration. 2
For the purposes of this guidance, a ll references to drugs include both human drugs a nd therapeutic biological products unless otherwise specified. 3
In a ddition to consulting guida nces, sponsors are encouraged to contact the Division to discuss specific issues that arise during the development of drugs for the treatment of CINV. 4
This guida nce includes recommendations for development programs for drugs for the prevention of CINV for pa tients receiving single-day antineoplastic therapy. FDA recommends that sponsors a ssess the efficacy, dosing, a nd sa fety of drugs for the prevention of CINV in pa tients receiving multiday antineoplastic therapy independently from those receiving single-day regimens.
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