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...
这些INDs用于临床试验之外的严重疾病患者,当没有可比或令人满意的替代疗法时,由主治执业医师提出申请,并由其确定收益是否大于可能的风险。请参阅FDA的最终指南: 有关更多信息,请参阅FDA的《最终指南:扩大治疗用研究药物的准入-问题》FDA's Final ...
Clinical Data Summary Pilot Program:临床研究试点计划,此部分介绍了CDER开放的临床研究试点计划,并提供了一份研究报告供参考; Drug Development Tools | DDTs:药品开发工具——DDTs; Guidance Documents for Drug Applications:药品申报指南性文件; Laws, Regulations, Policies and Procedures for Drug Applications:注册...
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: 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...
FURLS是FDA的电子注册系统,您可以在其中提交注册申请、更新注册信息以及查看注册状态。 3. FDA药物注册指南网站(CDER Guidance Documents):https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs 这个网站提供了关于药物注册的指南文件,包括注册要求、流程和相关政策。
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
https://www.fda.gov/regu latory⁃information/search⁃fda⁃guidance⁃documents/good⁃pharm acovigilance⁃practices⁃and⁃pharmacoepidemiologicassessment. [20] Hochberg AM, Pearson RK, O′Hara DJ, et al. Drug⁃versus⁃ drug adverse event rate comparisons: a pilot study based on data...
OHRP’s and FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe OHRP’s and FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited...
Guidance Documents (Medical Devices and Radiation-Emitting Products) - Guidance for Industry: Guidance for the Submission Of Premarket Notifications for Ma... Guidance Documents (Medical Devices and Radiation-Emitting Products) - Guidance for Industry: Guidance for the Submission Of Premarket Notifications...
FDA issued this draft guidance as part of a series of guidance documents to satisfy the Cures Act mandate and the PDUFA VI commitment. In the guidance, FDA covers a registry’s fitness-for-use for regulatory decision-making, focusing on attributes of a registry that support the collection of...