如果生产变更有可能对安全性产生不利影响,并且如果您未在IND中提交证据证明变更后的产品具有可接受的安全性,则您的IND可能会在临床开发的任何阶段被临床暂缓(clinical hold)(21 CFR 312.42(b)(1)(i)、21 CFR 312.42(b)(1)(iv)和 21 CFR 312.42(b)(2)(i))。可以分析可比性数据或与安全性相关的其他分析...
Silver Spring, MD 20993-0002,或致电1-800-835-4709 240-402-8010,或发送电子邮件至 ocod@fda.hhs.gov,或进入互联网网址https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-监管信息-生物制剂/生物制剂-指南。
原文链接如下: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions
This guidance focuses on submissions to FDA that rely on RWD/RWE to support a regulatory decision regarding product effectiveness and/or safety. Relevant submission types may include initial IND applications, meeting requests, s...
美国FDA 指导原则 IND提交的个体化反义寡核苷酸药物产品管理和程序建议 英文原版 35165469dft.docx 12/29/20IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators DRAFT GUIDANCE This guidance document is being ...
This guidance focuses on submissions to FDA that rely on RWD/RWE to support a regulatory decision regarding product effectiveness and/or safety. Relevant submission types may include initial IND applications, meeting requests, study protocols, and final study reports submitted to INDs, BLAs, or NDAs...
某些改变可能从根本上改变产品的设计或性质,从而产生新产品。用新的研究产品开始临床研究一般需要提交单独的IND(requires the submission of a separate IND)(21 CFR 312.20)。我们建议您就可能改变产品并需要提交新IND的任何生产变更征求FDA的意见(本指南第七节)。可能需要提交新IND的变更示例包括: ...
医生如果希望使用某一抗病毒产品,可以向FDA药品评价与研究中心(CDER)/抗病毒药物部(DAV)监管提出紧急IND(Emergency IND (Emergency Investigational New Drug (EIND)))申请。抗病毒药物部(DAV)负责监管正在开发的用于治疗由病毒(如流感、乙型肝炎、人类免疫缺陷病毒 1 [HIV-1] 和腺病毒)引起的感染的产品。对于不...
依据指南规定,申办方必须通过 FDA 的电子提交网关(Electronic Submission Gateway,ESG)或安全报告门户 (Safety Reporting Portal,SRP), 向FAERS 提交相关的 IND安全报告。 通过FAERS提交IND安全报告所涉范围 新公布的指南草案,不适用于严重和意外疑似不良事件之外的IND安全报告,诸如详细说明来自于其它研究的结果的报告,来...
2.Include the following information in your initial IND submission: ·Your product’s mechanism of action and QTPP, a list of initial potency-related CQAs and an explanation of how potency-related CQAs were identified. ·A description and justification of your potency assurance strategy. ...