序号
| 名称
| 发布单位 | 发布时间 | 文件下载 |
| 01 | Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products;Guidance for Industry CAR-T细胞产品开发的考虑;行业指南 | FDA | 1/2024 | pdf |
| 02 | Potency Assurance for Cellular and
Gene Therapy Products；Draft Guidance for Industry 细胞和基因疗法产品效力测试;行业指南 | FDA | 12/2023 | pdf |
| 03 | Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products 细胞与基因治疗产品的生产变更与可比性研究 | FDA | 7/2023
| pdf |
| 04 | Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry 细胞和基因治疗的早期临床试验中研究多形态问题；行业指南草案 | FDA | 11/2022 | pdf |
| 05 | Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry 神经退化性疾病的基因治疗产品研发;行业指南 | FDA | 10/2022 | pdf |
| 06 | Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry 包含人类基因编辑之人类基因治疗产品；行业指南草案 | FDA | 3/2022 | pdf |
| 07 | Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Draft Guidance for Industry CAR-T细胞产品相关开发考虑；行业指南草案
| FDA | 3/2022 | pdf |
| 08 | Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry 孤儿药管理条例下基因治疗产品的同一性解读；行业指南 | FDA | 9/2021 | pdf |
| 09 | Human Gene Therapy for Retinal Disorders; Guidance for Industry 视网膜疾病的人类基因治疗；行业指南 | FDA | 1/2020 | pdf |
| 10 | Human Gene Therapy for Rare Diseases; Guidance for Industry 罕见病的人类基因治疗；行业指南 | FDA | 1/2020 | pdf |
| 11 | Human Gene Therapy for Hemophilia; Guidance for Industry 血友病的人类基因治疗；行业指南 | FDA | 1/2020 | pdf |
| 12 | Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry 基因逆转录病毒载体的人类基因治疗产品在生产和患者随访过程中的检测；行业指南 | FDA | 1/2020 | pdf |
| 13 | Long Term Follow-up After Administration of Human Gene Therapy Products; Guidance for Industry 人类基因治疗产品给药后的长期随访；行业指南 | FDA | 1/2020 | pdf |
| 14 | Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Guidance for Industry 人类基因治疗研究新药申请（INDs）的化学、制造和控制（CMC）信息；行业指南 | FDA | 1/2020 | pdf |
| 15 | Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency; Guidance for Industry COVID-19突发公共卫生事件期间许可和研究性细胞和基因治疗产品的人类基因治疗的化学、制造和控制(CMC)信息；行业指南 | FDA | 1/2020 | pdf |
| 16 | Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff 人类细胞、组织、细胞和组织产品的监管考虑：最小操作和同源使用工业和食品药品监督管理局工作人员指南 | FDA | 12/2017 | pdf |
| 17 | Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry 用于基因治疗的微生物载体推荐；行业指南 | FDA | 9/2016 | pdf |
| 18 | Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry 基于病毒或细菌的基因治疗和溶瘤产物的脱落研究设计与分析；行业指南 | FDA | 8/2015 | pdf |
| 19 | Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry 细胞和基因治疗产品早期临床试验设计的思考；行业指南 | FDA | 6/2015 | pdf |
| 20 | Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry 确定基因疗法、载体疫苗和相关重组病毒或微生物产品环境评估的必要性和内容；行业指南 | FDA | 3/2015 | pdf |
| 21 | Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products 行业指南：研究性细胞和基因治疗产品的临床前评估 | FDA | 11/2013 | pdf |
| 22 | Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products 行业指南：细胞和基因治疗产品的效价试验 | FDA | 1/2011 | pdf |
| 23 | Guidance for Industry: Cellular Therapy for Cardiac Disease 行业指南：心脏疾病的细胞治疗 | FDA | 10/2010 | pdf |
| 24 | Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) FDA审稿人和申办者指南:人体细胞治疗研究新药申请(INDs)化学、制造和控制(CMC)信息的内容和审查 | FDA | 4/2008 | pdf |
| 25 | Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry 人类细胞、组织、细胞和组织产品供体的资格确定;行业指南 | FDA | 8/2007 | pdf |
| 26 | Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy 行业指南：人类体细胞治疗和基因治疗行业指南:人类体细胞治疗和基因治疗指南 | FDA | 3/1998 | pdf |
