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2016-06-26 09:00:31 作者：出处：
FDA Submissions — Refuse to Receive for Lack of Proper Justification of Impurity Limits
Guidance for Industry
DRAFT GUIDANCE
行业指南：ANDA申报---拒绝受理杂质限度缺乏适当论述的申报（草案）
This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
本指南仅供征求意见。关于本草案的建议和意见请在联邦注册上的通知公布后60天内，电子提交至上述网站。书面意见提交给上述地址。所有建议均应标明联邦注册上的档案编号。
For questions regarding this draft document contact (CDER) Elizabeth Giaquinto 240-402-7930.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
September 2014
Generic Drugs
ANDA Submissions —
Refuse to Receive for
Lack of Proper Justification of Impurity Limits
Guidance for Industry
Additional copies are available from:
Office of Communications
Division of Drug Information, WO51, Room 2201
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Silver Spring, MD 20993
Phone: 301-796-3400; Fax: 301-847-8714
druginfo@fda.hhs.gov
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
September 2014
Generic Drugs
TABLE OF CONTENTS
I. INTRODUCTION概述
II. BACKGROUND背景
III. JUSTIFYING IMPURITY LIMITS IN DRUG SUBSTANCES AND PRODUCTS. 原料药和制剂中杂质限度论述
A. Refusal to Receive for Lack of Impurities Information 因为缺少杂质资料而拒绝受理
B. Providing Proper Justification for Impurity Limits如何提交适当的杂质限度论述
ANDA Submissions – Refuse to Receive for Lack of Proper Justification of Impurity Limits
行业指南：ANDA申报---拒绝受理杂质限度缺乏适当论述的申报
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