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2016-09-16
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Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry; Availability
Notices
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D09002ee1bdc123e0
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry.'' The guidance document provides investigational new drug application (IND) sponsors, with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early phase clinical trials. The guidance focuses on the chemistry, manufacturing, and control (CMC) information that sponsors should submit in an IND for MVGTs and provides an overview of preclinical and clinical considerations for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2015 and supplements the guidance entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008.
81 FR 63766
https://www.govinfo.gov/app/details/FR-2016-09-16/2016-22353
2016-22353
fr16se16-68
4164-01-P
Docket No. FDA-2015-D-3399
https://www.govinfo.gov/app/details/FR-2016-09-16/2016-22353
https://www.govinfo.gov/content/pkg/FR-2016-09-16/html/2016-22353.htm
https://www.govinfo.gov/content/pkg/FR-2016-09-16/pdf/2016-22353.pdf
2 p.
63766
63767
81 FR 63766
Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry; Availability; Federal Register Vol. 81, Issue
NOTICE
2016-22353
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-D-3399
4164-01-P
2016-22353
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Recommendations for Microbial Vectors Used for Gene Therapy; Guidance for Industry.'' The guidance document provides investigational new drug application (IND) sponsors, with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early phase clinical trials. The guidance focuses on the chemistry, manufacturing, and control (CMC) information that sponsors should submit in an IND for MVGTs and provides an overview of preclinical and clinical considerations for these products. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2015 and supplements the guidance entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008.
Submit either electronic or written comments on Agency guidances at any time.
Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911.
Guidance:
Recommendations for Microbial Vectors Used for Gene Therapy
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 180
Office of the Federal Register, National Archives and Records Administration
2016-09-16
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-09-16
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https://www.govinfo.gov/content/pkg/FR-2016-09-16/pdf/FR-2016-09-16.pdf
https://www.govinfo.gov/content/pkg/FR-2016-09-16/xml/FR-2016-09-16.xml
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