临床研究产品和获批产品（包括生物制品）的生产必须符合FD&C法案规定的cGMP要求。比如I期临床样品应符合“CGMP for Phase 1 Investigational Drugs: Guidance for Industry,” July 2008的要求，II期及以后应符合21 CFR part 210 & 211的cGMP要求。BLA必须包含证明产品符合安全性，纯度和效价要求的数据，生产方法的完整...
• 基因编辑组件的生产要求需要根据临床研究满足适当的cGMP原则。1期临床对cGMP的要求可以参考“FDA Guidance for Industry: CGMP for Phase 1 Investigational Drugs“，2期临床及以后需要完全符合cGMP条件；• 基因编辑组件需要根据生产制定质量标准，标准中要对其安全项、鉴别、纯度、活性、残留进行规定。尤其是...
26.CGMP for Phase 1 Investigational Drugs; Guidance for Industry, July 2008, available at: https://www.fda.gov/media/70975/download. 27.S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; Guidance for Industr...
临床研究产品和获批产品(包括生物制品)的生产必须符合FD&C法案规定的cGMP要求。比如I期临床样品应符合“CGMP for Phase 1 Investigational Drugs: Guidance for Industry,” July 2008的要求,II期及以后应符合21 CFR part 210 & 211的cGMP要求。BLA必须包含证明产品符合安全性,纯度和效价要求的数据,生产方法的完整描述...
比如I期临床样品应符合“CGMP for Phase 1 Investigational Drugs: Guidance for Industry,” July 2008的要求,II期及以后应符合21 CFR part 210 & 211的cGMP要求。BLA必须包含证明产品符合安全性,纯度和效价要求的数据,生产方法的完整描述以及既定效期的产品稳定性数据。必须进行符合cGMP的工艺表征和工艺验证。
如果不能在变更前和变更后产品之间建立可比性,申请人应与FDA讨论(本指南第七部分)对变更后产品临床开发计划(clinical development program for the post-change product)的任何拟议修改。此类修改可包括增加接触变更后产品的受试者人数,以及用变更后产品启动新的临床研究。如果是要求有直接获益前景的儿科研究,在早期临床...
[20] FDA. Significant Risk and Nonsignificant Risk Medical Device Studies Information Sheet Gguidance for IRBs, Clinical Investigators, and Sponsors [EB/OL]. (2018-09- 06) [2023-08-23]. https://www. fda. gov/media/75459/ download. [21] FDA. CGMP for Phase 1 Investigational Drugs ...
“These regulations are really focused on commercial manufacturing and may not be appropriate for Phase I studies,” said Patel, noting that FDA has specific guidance on cGMP requirements for investigational drugs in Phase I studies. FDA exempted investigational drugs in Phase I studies from most cG...
(i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs,...
10. FDA Guidance for Industry: Comparability Protocols for Postapproval Changes to the 908 Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA, 909 October 2022,https://www.fda.gov/media/162263/download. 11. Guidance for Industry: CGMP for Phase I Investigational Drugs,...