2、FDA Guidance Documents (可查询指南性文件,如指导原则、法规等)这里提供一个方便的方法,从一个入口搜索所有的FDA相关的指导文件,例如:重点查看CGMP和CMC相关的指南更新情况: 3、Recalls, Market Withdrawals, & Safety Alerts 可查询产品的召回、撤市和安全警报等情况;召回、撤市和安全警报在FDA网站上可使用三年...
Database Search:可查询FDA收录的各种产品的溶 出方法;(3)Drugs@FDA Search: 可查询已批准上市药品的信息,包括说明书、审批 历史、综述、剂型、规格、理化性质等;(4)Orange Book:橙皮书,可查询已批准上市化学仿制药的信息,包括专利 情况;(5)Product-Specific Guidances for Generic Drug Development Database:可查...
4.5 Product-specific Guidances For Generic Drug Development Database 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),为广大药物工作者开发仿制...
for industry Dissolution Testing and Acceptance Criteria forImmediate-Release Solid Oral Dosage Form Drug Products Containing HighSolubility Drug Substances (August 2018). The information/data supporting thehigh solubility of the drug substance(s), as described in the BCS guidance (ICHguidance for ...
美国FDA 指导原则 全球唯一设备识别数据库(GUDID)工业和食品药品监督管理局工作人员指南 英文原版.pdf,Contains Nonbinding Recommendations Global Unique Device Identification Database (GUDID) Guidance for Industry and Food and Drug Administration Staff Documen
The article reports on the "Safety Labelling Changes-Implementation of Section 505(o)(4) of the FD&C Act" guidance released by the U.S. Food and Drug Administration (FDA) to clarify the safety labelling changes that may be required under Section 505(o)(4) of the act....
see the FDA Recognized Consensus Standards Database. The information in this guidance is intended to be used in conjunction with other FDA guidance documents, including device-specific guidances such as Infusion Pumps Total Product Life Cycle, and ...
Refer to FDA guidance for industry DeterminingWhether to Submit an ANDA or a 505(b)(2) Application (May 2019). 并不要求所拟仿制药采用与 RLD(参比制剂) 完全相同的容器密闭器系统(CCS)。但是 ANDA 一般必须包括有资料证明所拟仿制药具备相同的使用条件和相同的标签,允许与 RLD(参比制剂) 存在一定差异...
FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.
链接1: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115914.htm 链接2: Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments 相关链接: 转载此版本请保留出处,并注明转载自“国际药政通”(SYPHU-IFDPL)。