请参阅FDA的最终指南: 有关更多信息,请参阅FDA的《最终指南:扩大治疗用研究药物的准入-问题》FDA's Final Guidance: Expanded Access to Investigational Drugs for Treatment Use—Questions。 (5)问:如何提交IND申请? 答:根据IND的类型,提交修...
编写IND申请:IND申请包括详细的研究计划、药物化学信息、非临床数据、临床试验设计、研究人员背景等内容。申请文件应该遵循FDA的要求和指导文件,包括《新药临床试验指导原则》(Guidance for Industry - Investigational New Drug Applications (INDs))。 提交申请:将完整的IND申请文件提交给FDA。申请文件的提交方式可以是电子...
This guidance applies to submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) that containRWD/RWE intended to support a regulatory decision regarding...
This guidance applies to submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) that containRWD/RWE intended to support a regulatory decision regarding product safety and/or effectiveness. For the purposes of this guidance, ...
[22] FDA. Preparation of Investigational New Drug Products (Human and Animal) Guidance for Industry [EB/OL]. (2018-08-24) [2023-08-23]. https://www. fda. gov/media/ 71017/download. [23] FDA. Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring Guidance for ...
[29] FDA. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Draft Guidance for Industry [EB/OL]. (2023-09-22) [2024-05-20]. https:// www.fda.gov/media/172311/download. [30] FDA. Investigational New Drug Applications (INDs) — Determining Whether Human ...
1. 研究性新药(Investigational New Drug,IND) “研究性新药”(Investigational New Drug, IND)一般是指尚未经过审批、正在进行各阶段临床研究的新药。 IND主要反映FDA如何对在美国开展临床试验进行监管。IND申报后,FDA主要审查新药的安全性问题,并规定在30天之内答复申请人是否准予临床试验。若申请人在30天内没有得到...
美国FDA《指导原则》在药学(CMC——Chemistry,Manufacture and Control)项下明确指出:植物药CMC申报资料的技术要求不同于化学药,例如化学药的有效成分能够明确的定性鉴别和定量测定,而植物药有时则不能定性和定量地测定其有效成分,如果经研究证明确实如此,在其申报IND(Investigational New Drug,新药临床研究申请)或申请...
根据FD&C法案,新药(Investigational New Drug,IND)、NDA或351(a)BLA的申请人可以申请认定该平台技术,以便在新的或未来的申请中利用该技术,相关流程图示意如下: 1.平台技术认定资料准备及与FDA会议 申办者可在提交认定前与FDA讨论平台技术认定计划,提供概...
一般来说,在新药临床试验进行前后及过程中,可能进行的正式会议主要包括“研究性新药申请(investigational new drug application,IND申请)前会议”、“II期临床结束会议和III期临床前会议”、“新药申请(new drug application,NDA)或生物制品许可申请(biologi...