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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Statistical Evaluation of Stability Data, VICH GL51; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (<greek-i>219) entitled ``Draft Guidance for Industry on Statistical Evaluation of Stability Data, VICH GL51.'' This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guidance entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products, GL3(R)'' to propose a retest period or shelf life in a registration application.
77 FR 20406
https://www.govinfo.gov/app/details/FR-2012-04-04/2012-8039
2012-8039
fr04ap12-77
4160-01-P
Docket No. FDA-2012-D-0288
https://www.govinfo.gov/app/details/FR-2012-04-04/2012-8039
https://www.govinfo.gov/content/pkg/FR-2012-04-04/html/2012-8039.htm
https://www.govinfo.gov/content/pkg/FR-2012-04-04/pdf/2012-8039.pdf
2 p.
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77 FR 20406
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Statistical Evaluation of Stability Data, VICH GL51; Availability; Federal Register Vol. 77, Issue
NOTICE
2012-8039
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2012-D-0288
4160-01-P
2012-8039
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (<greek-i>219) entitled ``Draft Guidance for Industry on Statistical Evaluation of Stability Data, VICH GL51.'' This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guidance entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products, GL3(R)'' to propose a retest period or shelf life in a registration application.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 4, 2012.
Mai Huynh, Center for Veterinary Medicine, (HFV-142), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8273, Mai.huynh@fda.hhs.gov.
Guidance for Industry on Statistical Evaluation of Stability Data:
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
,
Mai.huynh@fda.hhs.gov
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm
http://www.regulations.gov
Federal Register
Vol. 77, no. 65
Office of the Federal Register, National Archives and Records Administration
2012-04-04
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