The FDA issued draft guidance for product labeling to help companies and agency review staff determine which established pharmacologic classes are appropriate for new drugs. A drug's labeling must include the product's established pharmacologic class under the "Indications and Usage" section so medical...
美国FDA 指导原则 索引结构化产品标签 英文原版.pdf,Guidance for Industry Indexing Structured Product Labeling U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Eva
美国FDA 指导原则 人体非处方药和处方药产品中钠、钾和磷的定量标签 英文原版.pdf,Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over- the-Counter and Prescription Drug Products Guidance for Industry DRAFT GUIDANCE This guidance documen
监管机构建议申请人包括一份“审阅者指引”(Reviewer’s Guide)如FDAeCTD技术合规指南《Technical Specifications Document》中所述,或一份列出所有变更的跟踪文件,并且建议申请人给予足够的时间(例如30天)供FDA在新批次临床试验材料放行前进行审查,具体参考《CMC GT INDs Guidance》【Reference. 7】...
Labeling Guidance Labeling Guidance ? How FDA Revie w s/App roves Labeling La beling ? FDA Labeling Initiatives FDA Labeling Initiatives Food Drug and Cosmetic Act Food Drug and Cosmetic Act (FD C Act) (FD C Act) ? Give s a uthority t o: –Interpret the law Interpret the law –...
the guidance gives recommendation that how the appropriate package type term appears on the labeling of injectable medical products for human use so the user will be able to easily identify the package type, which can assure safety use. However, there is no similar guidance in China at present...
other potential safety hazards enough to warrant inclusion in the WARNINGS AND PRECAUTIONS ination to include when describing those adverse reactions; and how to organize the WARNINGS AND PRECAUTIONS section 1 This guidance has been prepared by the Office of Medical Policy in the Center for Drug u...
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 ...
Product-Specific Guidances for Generic Drug Development Database仿制药开发的特定产品指南数据库 此部分收录了较多针对特定的仿制药开发的指南性文件,可根据原料药名称、RLD和RS号快速查询,也可根据时间查询最新的指南,查询结果包括原料药的剂型、给药方式、规格、临床试验思路、生物等效性以及指南的状态(终版或草案)...
Product-Specific Guidances for Generic Drug Development Database仿制药开发的特定产品指南数据库 此部分收录了较多针对特定的仿制药开发的指南性文件,可根据原料药名称、RLD和RS号快速查询,也可根据时间查询最新的指南,查询结果包括原料药的剂型、给药方式、规格、临床试验思路、生物等效...