Regulation&Guideline（FDA）

Regulation&Guideline（FDA）
No.	Regulation&Guideline	Issued by	Release time	Download
01	Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy	FDA	3/1998	pdf
02	Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry	FDA	8/2007	pdf
03	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	4/2008	pdf
04	Guidance for Industry: Cellular Therapy for Cardiac Disease	FDA	10/2010	pdf
05	Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products	FDA	1/2011	pdf
06	Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products	FDA	11/2013	pdf
07	Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry	FDA	3/2015	pdf
08	Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry	FDA	6/2015	pdf
09	Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry	FDA	8/2015	pdf
10	Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry	FDA	9/2016	pdf
11	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	FDA	12/2017	pdf
12	Human Gene Therapy for Retinal Disorders; Guidance for Industry	FDA	1/2020	pdf
13	Human Gene Therapy for Rare Diseases; Guidance for Industry	FDA	1/2020	pdf
14	Human Gene Therapy for Hemophilia; Guidance for Industry	FDA	1/2020	pdf
15	Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry	FDA	1/2020	pdf
16	Long Term Follow-up After Administration of Human Gene Therapy Products; Guidance for Industry	FDA	1/2020	pdf
17	Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Guidance for Industry	FDA	1/2020	pdf
18	Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency; Guidance for Industry	FDA	1/2021	pdf
19	Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry	FDA	9/2021	pdf
20	Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry	FDA	3/2022	pdf
21	Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Draft Guidance for Industry	FDA	3/2022	pd f
22	Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry	FDA	10/2022	pdf
23	Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry	FDA	11/2022	pdf

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