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2016-07-14
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Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Availability
Notices
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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 ``Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.'' The guidance document provides investigational new drug application (IND) sponsors with recommendations regarding IND submissions for early clinical trials with live biotherapeutic products (LBPs) in the United States. The guidance announced in this notice updates the guidance of the same title dated February 2012 (February 2012 guidance) by addressing when the label on the commercially available products(s) would be considered adequate to satisfy the purpose of the chemistry, manufacturing, and control (CMC) information requirements.
81 FR 43206
https://www.govinfo.gov/app/details/FR-2016-07-01/2016-15664
2016-15664
fr01jy16-73
4164-01-P
Docket No. FDA-2010-D-0500
https://www.govinfo.gov/app/details/FR-2016-07-01/2016-15664
https://www.govinfo.gov/content/pkg/FR-2016-07-01/html/2016-15664.htm
https://www.govinfo.gov/content/pkg/FR-2016-07-01/pdf/2016-15664.pdf
2 p.
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81 FR 43206
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Availability; Federal Register Vol. 81, Issue
NOTICE
2016-15664
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2010-D-0500
4164-01-P
2016-15664
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.'' The guidance document provides investigational new drug application (IND) sponsors with recommendations regarding IND submissions for early clinical trials with live biotherapeutic products (LBPs) in the United States. The guidance announced in this notice updates the guidance of the same title dated February 2012 (February 2012 guidance) by addressing when the label on the commercially available products(s) would be considered adequate to satisfy the purpose of the chemistry, manufacturing, and control (CMC) information requirements.
Submit either electronic or written comments on Agency guidances at any time.
Jessica T. Walker, 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:
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information
,
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. 127
Office of the Federal Register, National Archives and Records Administration
2016-07-01
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490 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-07-01
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0042-1219
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https://www.govinfo.gov/app/details/FR-2016-07-01
https://www.govinfo.gov/content/pkg/FR-2016-07-01/pdf/FR-2016-07-01.pdf
https://www.govinfo.gov/content/pkg/FR-2016-07-01/xml/FR-2016-07-01.xml
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