United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-11-23 article Notices D09002ee1c7fabde0 D09002ee1c7fabe66 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products" dated November 2013. The guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products reviewed by the Office of Cellular, Tissue and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, xenotransplantation, and certain biologic-device combination products, which OCTGT reviews. The guidance clarifies current expectations regarding the preclinical information that would support an investigational new drug application (IND) and a biologics license application (BLA) for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2012, and supersedes the recommendations in Section VIII in the guidance entitled "Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy" dated March 1998. 78 FR 70307 https://www.govinfo.gov/app/details/FR-2013-11-25/2013-28173 2013-28173 fr25no13-72 4160-01-P Docket No. FDA-2012-D-1038 https://www.govinfo.gov/app/details/FR-2013-11-25/2013-28173 https://www.govinfo.gov/content/pkg/FR-2013-11-25/html/2013-28173.htm https://www.govinfo.gov/content/pkg/FR-2013-11-25/pdf/2013-28173.pdf 1 p. 70307 70307 78 FR 70307 Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Availability; Federal Register Vol. 78, Issue NOTICE 2013-28173 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-D-1038 4160-01-P 2013-28173 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products" dated November 2013. The guidance document provides sponsors and individuals that design and implement preclinical studies with recommendations on the substance and scope of preclinical information needed to support clinical trials for investigational products reviewed by the Office of Cellular, Tissue and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination, xenotransplantation, and certain biologic-device combination products, which OCTGT reviews. The guidance clarifies current expectations regarding the preclinical information that would support an investigational new drug application (IND) and a biologics license application (BLA) for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2012, and supersedes the recommendations in Section VIII in the guidance entitled "Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy" dated March 1998.

Submit either electronic or written comments on Agency guidances at any time. Tami Belouin, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210. Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 78, no. 227 Office of the Federal Register, National Archives and Records Administration 2013-11-25 continuing daily deposited born digital 307 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-11-25 P0b002ee18660d1dd 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr25no13 https://www.govinfo.gov/app/details/FR-2013-11-25 https://www.govinfo.gov/content/pkg/FR-2013-11-25/pdf/FR-2013-11-25.pdf https://www.govinfo.gov/content/pkg/FR-2013-11-25/xml/FR-2013-11-25.xml fdlp 70189 70483 DGPO 2013-11-23 2024-06-03 FR-2013-11-25 machine generated eng FR FR-2013-11-25 78 227