CF 囊肿性纤维化,亦称为奏性纤维化、囊肿性纤维 变性或囊纤维变性;猴性纤维性变病 cytokine 细胞因子 cytokine storm 细胞因子风暴4 cytostatic 细胞抑制 cytotoxic drugs 细胞毒性药物 data mining 数据挖掘 Data Safety And Monitoring Board = DSMB55 数据安全及监控委员会 DBS = deep brain stimulation 脑深部...
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...
38、 CenterDMIDDivision of Microbiology and Infectious Diseases, NIAID, NIHDSMBData Safety and Monitoring BoardDSMCData Safety and Monitoring CommitteeFDAFood and Drug AdministrationFWAFederal-Wide AssuranceGCPGood Clinical PracticeHIPAAHealth Insurance Portability and Accountability ActIBInvestigators 39、Broch...
GuidanceforIndustryBotanicalDrugProductsguidingcatheter HACCP82=HazardAnalysisandCriticalControlPointHAI=healthcare-associatedinfections hallucinogensHalophiles handlingandstorage 仿制药品;非专利药品;通用名药;非专利名称 基因泰克 遗传毒性试验遗传脆弱性基因型
The guidance provided below is detailed and is intended to notify the applicant of virtually all of the information that should routinely be provided so that postsubmission requests for further data clarification and analyses can be reduced as much as possible. Nonetheless, specific requirements for ...
This paper introduces the guidance in detail, focusing on the random umbrella and platform design that provide substantial evidence for safety and effectiveness, and discusses the important considerations for the design and analysis of the master protocol. Combined with the requirements of the current ...
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...
However, the sponsor need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. The firm must show that its device addresses the issues of safety and effectiveness identified in this guidance, either by ...
[23] FDA. Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring Guidance for Industry [EB/OL]. (2013-08-07) [2023-08-23]. https://www. fda. gov/media/116754/download. [24] ICH. E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-...
This guidance provides recommendations to sponsors of drugs or biologics for the treatment of cancer regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master...