S.20.05 NIMH/FDA guidelines for clinical trials for cognition in schizophrenia: how much have we advanced?doi:10.1016/s0924-977x(10)70204-2S. MarderR.W. BuchananElsevier BVEuropean Neuropsychopharmacology
New FDA guidelines on clinical trials in womenReports on the United States Food and Drug Administration's guidelines on clinical trials in women. Drug development tests; Effects of concurrent medications on wome...
从http://Clinicaltrials.gov出发：所有的临床试验都需要注册，但不是所有的临床试验都是为了产品的注册...
FDA还提出了全球基因疗法合作(Gene Therapies Global (CoGenT Global) Pilot)试点、支持推进罕见病治疗的临床试验(Support for clinical Trials Advancing Rare disease Therapeutics)(START)试点以及针对罕见病的RDEA(Rare Disease Endpoint Advancement )机制;以及平台技术应用的提供(Application of platform technology provisi...
Considerations for Inclusion in Clinical Trials Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice ...
本次培训的目标是了解 FDA 对知情同意的期望、审查在知情同意中促进参与者理解的方法等。 视频加载失败,请刷新页面再试 刷新 Copy right Owned by FDA FROM You Tube. 50.20知情同意的一般要求:FDA法规要求调查人员在极少数例外情况下,在受试者参加FDA...
2024年12月:美..根据美国FDA官网显示,2024年12月已对多款“first-in-class”新药、新适应症的批准做出监管决定,其中包括治疗家族性高乳糜微粒血症综合征、特应性皮炎、囊性纤维化、血友病和阻塞性睡眠呼吸
该申请得到了关键性 3 期 EASE-1 试验(ClinicalTrials.gov 标识符:NCT03690206)、两项长期扩展研究(EASE-2;ClinicalTrials.gov 标识符:NCT03905707)和 EASE-3;ClinicalTrials.gov 标识符:NCT04881825)以及一项机制试验(EASE-4;ClinicalTrials.gov 标识符:NCT049913)的数据支持,这些试验旨在研究格帕鲁肽对肠道吸收的...
与ClinicalTrials.gov相关的强制逐字声明 关键拟议修订21 CFR第50部分 • 关键信息(拟议的50.20(d)和(e)) • 知情同意的附加基本要素(建议 50.25(b)(9)) • 知情同意的附加要素(建议 50.25(a)(7)-(9)) FDA表示知情同意文件通常冗长、复杂且具有法律效力、需要开展更多的工作来兑现以参与者为中心的知...
When planning and when reporting such trials, contact with regulatory authorities to discuss an appropriate report format is encouraged. The provisions of this guideline should be used in conjunction with other ICH guidelines. 1. TITLE PAGE The title page should contain the following information: ...