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2015-08-27
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Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry; Availability
Notices
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D09002ee1c180c4c7
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 ``Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry.'' The guidance document provides sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical development. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2014.
80 FR 52047
https://www.govinfo.gov/app/details/FR-2015-08-27/2015-21235
2015-21235
fr27au15-60
4164-01-P
Docket No. FDA-2014-D-0852
https://www.govinfo.gov/app/details/FR-2015-08-27/2015-21235
https://www.govinfo.gov/content/pkg/FR-2015-08-27/html/2015-21235.htm
https://www.govinfo.gov/content/pkg/FR-2015-08-27/pdf/2015-21235.pdf
1 p.
52047
52047
80 FR 52047
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-21235
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-D-0852
4164-01-P
2015-21235
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry.'' The guidance document provides sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical development. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2014.
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:
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 80, no. 166
Office of the Federal Register, National Archives and Records Administration
2015-08-27
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248 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-08-27
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0042-1219
0364-1406
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https://www.govinfo.gov/app/details/FR-2015-08-27
https://www.govinfo.gov/content/pkg/FR-2015-08-27/pdf/FR-2015-08-27.pdf
https://www.govinfo.gov/content/pkg/FR-2015-08-27/xml/FR-2015-08-27.xml
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2015-08-27
2023-10-16
FR-2015-08-27
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FR
FR-2015-08-27
80
166