[3]Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry, January 2020, https://www.fda.gov/media/113760/download. [16]Guid...
1.FDA 的电子通用技术文档(eCTD)技术合规指南(eCTD Technical Conformance Guide) 2.FDA 的行业指南《药械组合产品现行良好生产规范要求》(guidance for industry, Current Good Manufacturing Practice Requirements for Combination Products) ...
与其他类型的FDA会议一样,这项会议的准备工作始于正式的会议申请。按照FDA的指导原则,该申请应包括有关产品的信息(名称、产品和申请号、化学结构)、适应症、申请类型(NDA/BLA/生物类似药)、会议类型和目的(Pre-NDA CMC或Pre-NDA Clinical)、会议目标、需要与FDA咨询的问题、计划出席者和要求出席的FDA人员、建议的...
The FDA has issued its guidance for chemistry, manufacturing, and control information that is included in investigational new drug applications (INDs) for gene therapies, called “Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Dr...
美国FDA 指导原则 年度报告CMC部分的格式和内容 英文原版.pdf,Guidance for Industry Format and Content for the CMC Section of an Annual Report Center for Drug Evaluation and Research (CDER) September 1994 GUIDANCE FOR INDUSTRY1 FORMAT AND CONTENT FOR THE CM
IND中的CMC信息说明申请人承诺按照IND或相互参照的IND(cross-referenced IND)或主文件中的规定对研究产品进行生产和测试。如果生产变更可能影响产品质量,我们认为必须在IND的信息修订中提交生产变更的基本信息(21 CFR 312.31(a)(1))。申办者应在临床研究中使用变更后的产品之前提交此类修订(information amendment),供...
• “FDA 审评员和申办方指南：人类体细胞疗法新药研究申请 (IND) 的化学、制造和控制 (CMC) 信息的内容和审查”指南, 2008年4月发布, 细胞疗法 CMC 指南。Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels: Guidance for Industry 2024年4月30日，FDA发布了一...
1. Guidance for Industry: Q9 Quality Risk Management, June 2006, https://www.fda.gov/media/71543/download. 2. Guidance for Industry: Q10 Pharmaceutical Quality System, April 2009, https://www.fda.gov/media/71553/download. 3. Guidance for Industry: Q8(R2) Pharmaceutical Development, November...
8. Guidance for Industry: Preclinical Assessment of Investigational Cellular and GeneTherapy Products, November 2013,https://www.fda.gov/media/87564/download. 9. Guidance for Industry: M4Q: The CTD – Quality, August 2001,https://www.fda.gov/media/71581/download. ...
本指南的其他副本可从通信、外联和发展办公室(OCOD)(HFM-40)获取,地址:马里兰州罗克维尔市罗克维尔派克1401号,200N室,邮编:20852-1448,或致电1-800-835-4709或301-827-1800,或发送电子邮件到ocod@fda.hhs.gov,或官网http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances...