该新要求与目前的要求不同,两者区别见表 1。 表1FDA对处方药说明书特殊人群用药新旧要求对比Table 1Comparison on current prescription drug labeling with new PLLR labeling requirements 新要求还删除了妊娠字母分类A、B、C、D和X。FDA认为这种分类往往混乱,并且不准确或不一致地传递胎儿风险程度的差异,可导致不明...
FDA's requirements for clinical pharmacology section of prescription drug labelingXIAO Hui-lai 发布日期:2017-05-26摘要 访问统计 PDF预览 参考文献 相似文献 [关键词] 美国食品药品管理局 ; 处方药说明书 ; 临床药理学项目 ; 指导原则 [摘要] 美国食品药品管理局(FDA)于2016年12月发布了“人用处方药和...
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 It was current when produced, but is no longer maintained and may be outdated.
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60...
or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing. [Note: Newly approved products are added to parts 1, 2, or 3 of the List, depending on the disp...
美国FDA药物标签介绍 CDER CDER Forum Forum for International for International Drug Regulatory Authorities Drug Regulatory Authorities April 15, 2008 April 15, 2008 Labeling Labeling Overview Overview Jeanne M. Delasko, RN, MS Jeanne M. Delasko, RN, MS Label Initiatives Specialist Label Initiatives ...
1、FDA s Bar Code Label Requirementsfor Human Drug ProductsGeneral Questions Related to Drugs and BiologicsFDA QuestionHDMA Response1. Which medical products should carry a bar code? For example, should all prescription and over-the-counter (OTC) drugs be bar coded? Should blood products and ...
关键词: 处方药; 标签; 标识; 用药错误; 指导原则 中图分类号: R97; R951 文献标志码: A 文章编号: 1674 - 5515(2014)01 - 0086 - 06 DOI: 10.7501/j.issn.1674-5515.2014.01.021 Requirements by FDA for container labels and carton labeling of prescription drugs XIAO Hui-lai Center for Drug ...
Food and Drug Administration's (FDA) authority to monitor drug labeling practices. Topics include the preemption of state laws by the FDA, federal labeling requirements, and the regulation of medical devices. Information is provided on medical company compliance with FDA regulations....
(CBER) October 2011 Labeling Warnings and Precaut Contraindications, and Bo Warning Sections of Labe Biological Products — Guidance for Industry ions, xed ling for Human Prescription Drug and Biological Products — Content and at ilable from: Dsion of Drug Ination 101 New Hampshire Ave. 0993 ...