2023年5月,FDA发布了Draft Guidance for Industry, Investigators, and Other Stakeholders Decentrialized Clinical Trials for Drugs, Biological Products, and Devices (以下简称“DCT指引(征求意见稿)”),从多个实践操作的角度提出了对去中心化临床试验(“DCT”)实施的建议。这是继FDA于2021年12月发布对行业、研究...
We (FDA) recommend that you use this guidance as a companion to otherFDA guidance documents describing the chemistry, manufacturing, and control (CMC) information submitted and reviewed in an IND application for phase 1 clini...
美国FDA 指导原则 INDS(研究性新药应用)和BA BE(生物利用度生物等效性)研究的安全报告要求 英文原版.pdf,Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies U.S. Department of Health and Human Services Food and Drug
1.FDA. Guidance for Industry: Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products. Aug, 2019. Retrieved Aug 29, 2019 from https://www.fda.gov/media/130326/download 2.FDA. Guidance for Industry and Investigators. Safety Reporting Requirements for ...
· As stated in the guidance for industry and investigators Safety Reporting Requirements for INDs and BA/BE Studies (December 2012), FDA recommends unblinding the patient and the investigator when the patient has an adverse event suspected to be related to the investigational drug product and for...
We (FDA) recommend that you use this guidance as a companion to otherFDA guidance documents describing the chemistry, manufacturing, and control (CMC) information submitted and reviewed in an IND application for phase 1 clinical trials.In many cases, at this stage of development manufacture of th...
FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic FDA关于在COVID-19疫情期间开展药品临床试验的指南 Guidance for Industry, Investigators, and Institutional Review Boards 行业、研究者和机构审查委员会指南
最近莫老大哥凭着“483”又火了一把,而且ORA,CDER,CVM,CDRH在6月份联合修订并发布了一份关于在FDA检查时,企业如果延误,否认,限制或拒绝行为时的指南:<Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device I...
美国FDA 指导原则 美国食品药品监督管理局新冠肺炎期间医疗产品临床试验指南行业、调查人员和机构审查委员会指南 英文原版.pdf,Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Guidance for Industry, Investigators, and I
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Draft Guidance for Industry, IRBs, and Clinical Investigators 2024年4月25日，FDA发布了三份肿瘤临床试验入排标准相关的指南，分别关于“洗脱期和伴随药物”、“活动状态（Performance Status, PS）”和“实验室指标”，为CDER和CBER监管的用于癌症治疗...