FDA-NDA新药Ⅰ期临床试验申报资料(英语原文)

更新时间:2023-07-06 15:08:54 阅读: 评论:0

FDA-NDA新药Ⅰ期临床试验申报资料(英语原文)
Guidance for Industry
Content and Format of Investigational New Drug Applications (INDs) for Pha 1 Studies of Drugs, Including
Well-Characterized, Therapeutic, Biotechnology-derived Products
Center for Drug Evaluation and Rearch (CDER) Center for Biologics Evaluation and Rearch (CBER)
November 1995多大能办身份证
CLIN 2
TABLE OF CONTENTS
I.INTRODUCTION (1)o型血女生
II.CURRENT REQUIREMENTS AND PRACTICES (2)
III.CLARIFICATIONS OF PRESENT IND REGULATIONS (2)
A.Cover Sheet (3)
B.Table of Contents (3)
C.Introductory Statement and General Investigational Plan (3)
D.Investigator's Brochure (3)
E.Protocols (3)
F.Chemistry, Manufacturing, and Control Information (4)
G.Pharmacology and Toxicology Information (10)
H.Previous Human Experience with the Investigational Drug (14)
I.21 CFR 312.23(a)(10), (11) and (b), (c), (d), and (e) (14)
IV.REFERENCES (14)
i
学会生活
This guidance has been prepared by the Center for Drug Evaluation and 1Rearch (CDER) and the Center for Biologics Evaluation and Rearch (CBER) at the Food and Drug Administration. Although this guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the industry, it does reprent the agency’s current thinking on data requirement issues related to the initial entry of an unapproved drug into human studies in the United States. For
additional copies of this guidance, contact the Consumer Affairs Branch (formerly the Executive Secretariat Staff), HFD-210, CDER, FDA, 5600 Fishers Lane, Rockville, MD 20857 (Phone: 301-594-1012) or the Congressional and Consumer Affairs Branch (HFM-12), CBER, FDA, 1401 Rockville Pike (STE 200N), Rockville, MD 20852-1448(Phone: 301-594-1800 or 800-835-4709). An electronic version of this guidance is also available via Internet by connecting to the CDER file transfer protocol (FTP)rver (
电影配乐m/doc/137698177.html,).
As ud throughout this guidance, the term "drugs" includes well-characterized,2therapeutic, biotechnology-derived products.
涤棉是什么材质GUIDANCE FOR INDUSTRY 1
CONTENT AND FORMAT
OF INVESTIGATIONAL NEW DRUG APPLICATIONS (INDs) FOR PHASE 1 STUDIES OF DRUGS, INCLUDING WELL-
CHARACTERIZED, THERAPEUTIC, BIOTECHNOLOGY-DERIVED
光学基础知识
PRODUCTS
I.INTRODUCTION
With FDA's recent success in meeting the Prescription Drug Ur Fee Act of 1992 (PD
UFA) review action performance goals, and the resulting significant declines in mean and median time from submission of a marketing application to approval for marketing, attention has turned to increasing the efficiency of other components of the drug development process without sacrificing the long-
standing safety and efficacy standards Americans expect their drug products to meet. One part of IND regulation of particular interest - under active discussion for more than two years and the subject of various degrees of attention since the McMahon Committee - is the regulation of the initial testing of drugs in humans (i.e., Pha 1 trials).
This guidance clarifies requirements for data and data prentation in 21 CFR 312.22 and 312.23 related to the initial entry into human studies in the United States of an investigational drug, including well-characterized, therapeutic,biotechnology-derived products . Prent regulations allow a great deal of 2
商检英文flexibility in the amount and depth of various data to be submitted in an IND
depending in large part on the pha of investigation and the specific human
testing being propod. In some cas, the extent of that flexibility has not been appreciated. FDA believes clarifications of many of the requirements will help expedite entry of new drugs into clinical testing by increasing transparency and reducing ambiguity and inconsistencies, and by reducing the amount of
information submitted, while providing FDA with the data it needs to asss the safety of the propod Pha 1 study. If the guidance specified in this
document is followed, IND submissions for Pha 1 studies should usually not
be larger than two to three, three inch, 3-ring binders ("jackets").
漳州四果汤
The most significant clarifications are: 1) the explicit willingness to accept an
integrated summary report of toxicology findings bad upon the unaudited draft toxicologic reports of completed animal studies as initial support for human
studies, and 2) specific manufacturing data appropriate for a Pha 1
investigation. For products not covered by this Guidance, other FDA guidance documents should be consulted. In addition, the Center responsible for the
product may be contacted for guidance.
Becau of the manufacturing and toxicologic differences between well-
characterized, therapeutic, biotechnology-derived products and other biologic
products, this Guidance only applies to drugs and well-characterized,

本文发布于:2023-07-06 15:08:54,感谢您对本站的认可!

本文链接:https://www.wtabcd.cn/fanwen/fan/89/1070356.html

版权声明:本站内容均来自互联网,仅供演示用,请勿用于商业和其他非法用途。如果侵犯了您的权益请与我们联系,我们将在24小时内删除。

标签:资料   临床试验   身份证
相关文章
留言与评论(共有 0 条评论)
   
验证码:
推荐文章
排行榜
Copyright ©2019-2022 Comsenz Inc.Powered by © 专利检索| 网站地图