当地时间8月15日(周二),美国食品药品监督管理局(FDA)重磅发布《知情同意指南(Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors)》定稿,旨在为机构审查委员会(IRB)、临床研究者和研究申办者提供FDA关于知情同意的法规要求。 截图自ICG文件,以下均为此来源 该指南的征求意见稿在2014年7月发...
Step 1– Determine That There is Sufficient Justification to Enroll the Subject Without Using a Translated Long Form to Document the Subject’s Informed Consent Step 2– Obtain and Document the Subject’s Informed Consent in Accordance with FDA Regulations at 21 CFR 50.20, 2...
Upcoming: FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference 美东时间2024年11月6日至7日, BIMO-W与SOCRA将联合举办一场题为“FDA临床试验要求、法规、合规性和GCP会议”的研讨会，旨在帮助临床研究专业人员理解FDA的使命、职责和权力，并鼓励其与FDA代表互动。本次会议的目的是请FDA代...
FDA intends to promulgate regulations to permit this exception and to specify appropriate human subject protection safeguards. FDA issued guidance in July 2017 for sponsors, investigators, and IRBs on enforcement of FDA regulations governing informed consent requirements for clinical investigations that ...
study involving human subjects that it either was conducted in compliance with the institutional review board regulations in Part 56, or was not subject to the regulations under section 56.104 or section 56.105, and that it was conducted in compliance with the informed consent regulations in Part ...
to verifythe accuracy, reliability, and integrity of clinical and nonclinical trial datasubmitted to FDA; and to assess compliance with FDA’s regulations governing theconduct of clinical and nonclinical trials, including regulations for informedconsent and ethical review, and certain postmarketing require...
美国FDA已经批准了42款生物仿制药产品,包括4款可互换生物仿制药,对生物仿制药以及可互换生物仿制药的标签所需要考虑的事项也已经累积了宝贵的经验。本指南基于相关经验,为可互换生物仿制药产品的标签提供了建议,同时包含其他议题。如需了解如何提交评论,请访问https://www.r...
A non-profit believes the risk is substantial, but that informed consent paperwork generally fails to mention animal testing and the extent to which this can predict whether a drug is safe to give to humans. And so the Center for Responsible Medicine wants the FDA to upgrade its regulations ...
Upcoming:FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference 美东时间2024年3月20日-3月21日,BIMO-W和SOCRA将联合举办一次题为“FDA 临床试验要求、法规、合规性和 GCP 会议”的研讨会。 该研讨会旨在让FDA代表和受监管社区之间分享信息,促进对法规、指南和实践的理解,并提出增强研究专...
You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations. 本函并非企业临床试验药物研究缺陷的全面清单。企业有责任确保遵守法律和FDA相关法规的每一项要求。企业应该解决任何缺陷,并建立程序以确保任何正在进行或未来的研究符合FDA法规。