| 序号 | 名称 | 适用范围 | 发布日期 | 链接 |
| 1 | Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing 《使用下一代测序评估人类基因治疗产品中基因组编辑的安全性》 | Draft Guidance for Industry | 04/2026 | 查看 |
2 | Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products 在细胞和基因治疗以及组织工程医疗产品的制造中使用人类和动物源性材料的注意事项 | Guidance for Industry | 04/2024 | |
3 | Human Gene Therapy Products Incorporating Human Genome Editing 结合人类基因组编辑的人类基因治疗产品 | Guidance for Industry | 01/2024 | |
4 | Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products 嵌合抗原受体（CAR）T 细胞产品开发的考虑因素 | Guidance for Industry | 01/2024 | |
5 | Human Gene Therapy Incorporating Human Genome Editing 结合人类基因组编辑的人类基因治疗产品 | Guidance for Industry | 01/2024 | |
6 | Potency Assurance for Cellular and Gene Therapy Products 细胞和基因治疗产品的效力保证 | Guidance for Industry | 12/2023 | |
7 | Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products 人类细胞和基因治疗产品的制造变化和可比性 | Guidance for Industry | 07/2023 | |
8 | Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide 人体细胞、组织以及细胞和组织产品（HCT/Ps）的监管 - 小实体合规指南 | Guidance for Industry | 11/2022 | |
9 | Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial 在早期临床试验中研究细胞或基因治疗产品的多个版本 | Guidance for Industry | 11/2022 | |
10 | Human Gene Therapy for Neurodegenerative Diseases 人类神经退行性疾病基因疗法 | Guidance for Industry | 10/2022 | |
11 | Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations 解读孤儿药法规下基因治疗产品的相同性 | Guidance for Industry | 09/2021 | |
12 | Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency COVID-19 公共卫生紧急情况期间许可和研究性细胞和基因治疗产品的制造注意事项 | Guidance for Industry | 01/2021 | |
13 | Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use 人体细胞、组织以及细胞和组织产品的监管注意事项：最小化操作和同源使用 | Guidance for Industry | 07/2020 | |
14 | Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up 在产品制造和患者随访过程中测试基于逆转录病毒载体的人类基因治疗产品的复制能力逆转录病毒 | Guidance for Industry | 01/2020 | |
15 | Human Gene Therapy for Retinal Disorders 人类视网膜疾病基因疗法 | Guidance for Industry | 01/2020 | |
16 | Human Gene Therapy for Rare Diseases 罕见疾病的人类基因疗法 | Guidance for Industry | 01/2020 | |
17 | Human Gene Therapy for Hemophilia 血友病的人类基因疗法 | Guidance for Industry | 01/2020 | |
18 | Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) 人类基因治疗研究性新药申请（IND）的化学、制造和控制（CMC）信息 | Guidance for Industry | 01/2020 | |
19 | Long Term Follow-up After Administration of Human Gene Therapy Products 人类基因治疗产品施用后的长期随访 | Guidance for Industry | 01/2020 | |
20 | Evaluation of Devices Used with Regenerative Medicine Advanced Therapies 再生医学先进疗法所用设备的评估 | Guidance for Industry | 02/2019 | |
21 | Expedited Programs for Regenerative Medicine Therapies for Serious Conditions 严重疾病再生医学治疗的快速计划 | Guidance for Industry | 02/2019 | |
22 | Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception 21 CFR 1271.15 (b) 规定的相同手术程序例外：有关例外范围的问题与解答 | Guidance for Industry | 11/2017 | |
23 | Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271 仅根据《公共卫生服务法》第 361 条和 21 CFR 第 1271 部分监管的人体细胞、组织以及细胞和组织产品的偏差报告 | Guidance for Industry | 09/2017 | |
24 | Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates 关于确定已接受人源凝血因子浓缩物的人体细胞、组织以及细胞和组织产品捐赠者资格的修订建议 | Guidance for Industry | 11/2016 | |
25 | Recommendations for Microbial Vectors Used for Gene Therapy 用于基因治疗的微生物载体的建议 | Guidance for Industry | 09/2016 | |
26 | Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products 基于病毒或细菌的基因治疗和溶瘤产品的脱落研究的设计和分析 | Guidance for Industry | 08/2015 | |
27 | CVM GFI #218 Cell-Based Products for Animal Use CVM GFI #218 动物用细胞产品 | Guidance for Industry | 06/2015 | |
28 | Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products 细胞和基因治疗产品早期临床试验设计的注意事项 | Guidance for Industry | 06/2015 | |
29 | Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products 确定基因疗法、载体疫苗和相关重组病毒或微生物产品的环境评估的必要性和内容 | Guidance for Industry | 03/2015 | |
30 | IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System 针对患有影响造血系统疾病的患者进行造血和免疫重建的微创、无关同种异体胎盘 / 脐带血的 IND 申请 | Guidance for Industry and FDA Staff | 03/2014 | |
31 | BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System 针对造血系统疾病患者的造血和免疫重建的微创、无关同种异体胎盘 / 脐带血的 BLA | Guidance for Industry | 03/2014 | |
32 | Preclinical Assessment of Investigational Cellular and Gene Therapy Products 研究性细胞和基因治疗产品的临床前评估 | Guidance for Industry | 11/2013 | |
33 | Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage 膝关节软骨修复或置换产品的 IDE 和 IND 准备工作 | Guidance for Industry | 11/2011 | |
34 | Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 现行良好组织规范（CGTP）及针对人体细胞、组织及细胞和组织基产品（HCT/Ps）制造商的附加要求 | Guidance for Industry | 11/2011 | |
35 | Clinical Considerations for Therapeutic Cancer Vaccines 治疗性癌症疫苗的临床注意事项 | Guidance for Industry | 10/2011 | |
36 | Potency Tests for Cellular and Gene Therapy Products 细胞和基因治疗产品效力测试 | Guidance for Industry | 01/2011 | |
37 | Cellular Therapy for Cardiac Disease 心脏疾病细胞治疗指南 | Guidance for Industry | 10/2010 | |
38 | Considerations for Allogeneic Pancreatic Islet Cell Products 同种异体胰岛细胞产品的注意事项 | Guidance for Industry | 09/2009 | |
39 | Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests 通过混合标本或诊断测试检测传染病的供体中提取的人类细胞、组织和细胞及组织基产品（HCT/Ps） | Guidance for Industry | 04/2008 | |
40 | Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) 人体细胞治疗研究性新药申请（IND）化学、制造和控制（CMC）信息内容与审查指南 | Guidance for FDA Reviewers and Sponsors | 04/2008 | |
41 | Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products 人体细胞、组织及基于细胞和组织产品（HCT/Ps）供体资格确定 | Guidance for Industry | 08/2007 | |
42 | Guidance for Human Somatic Cell Therapy and Gene Therapy 人体细胞治疗和基因治疗指南 | Guidance for Industry | 03/1998 | |
