1. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)).你们公司未能建立适当的质量部门，适用于质量部门的职责和程序，没有文件化，且未严格遵循［21...
美国FDA药品标签法规要求 U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
within 60 days after the date of the de- Subpart C—Labeling Requirements for cision involved will be denied as un- Over-the-Counter Devices timely, unless CDRH, for good cause, permits the request to be filed after 60 801.60 Principal display panel. 801.61 Statement of identity. days. An...
A labeler may submit a request for an exception from or alternative to the requirement for the label of a device to bear a unique device identifier (§ 801.20) or other UDI requirement under21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification)for a specified device or ...
1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额QUOTAS 1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS 1305 令的格式ORDER FORMS 1306 处方PRESCRIPTIONS 1307 杂项MISCELLANEOUS 1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES 1309 表I化学品的...
1302 对管制物质的标识与包装要求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额QUOTAS 1304 登记者的记录与报告 RECORDS AND REPORTS OF REGISTRANTS 1305 令的格式 ORDER FORMS 1306 处方PRESCRIPTIONS 1307 杂项MISCELLANEOUS 1308 管制物质的表 SCHEDULES OF CONTROLLED SUBSTANCES 1309 表I...
1302 对管制物质的标识与包装要求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额 QUOTAS 1304 登记者的记录与报告 RECORDS AND REPORTS OF REGISTRANTS 1305 令的格式 ORDER FORMS 1306 处方 PRESCRIPTIONS 1307 杂项 MISCELLANEOUS
REQUIREMENTS 328 含有酒精的预期用于口部摄入的非处方药品 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL 一般认为安全与有效以及不错误标识的非处方人用药品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED 用于非...
医疗器械标签的相关指导原则由FDA下属的器械和辐射健康中心(CDRH)负责起草,分别1989年发布的医疗器械标签管理规范(Labeling regulatory requirements for medical device)和1991年发布的医疗器械标签和说明书指导原则(Device Labeling Guidance)。 1.2指导原则概况
美国FDA《联邦规章典集》(CFR)第21篇目录中文版 发布时间:2010-5-1113:44:12发布方:奥咨达医疗器械咨询 美国《联邦规章典集》(CFR)第21篇“食品与药品”总目 概述:美国《联邦规章典集》(CodeofFederalRegulations,CFR)第21篇“食品与药品(”Title21―FoodandDrugs)共有9卷(Volume)、 3章(Chapter)、1499部(Pa...