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2020-04-14
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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV; Guidance for Industry; Availability
Notices
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D09002ee1c2a57fd0
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 final guidance for industry (GFI) #259 entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV'' (VICH GL58). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is an annex to the VICH parent stability guidance, GFI #73 (VICH GL3(R)), ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision),'' and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration or application submitted within the regions in climatic zones III and IV.
85 FR 20693
https://www.govinfo.gov/app/details/FR-2020-04-14/2020-07752
2020-07752
fr14ap20-56
4164-01-P
Docket No. FDA-2018-D-4662
https://www.govinfo.gov/app/details/FR-2020-04-14/2020-07752
https://www.govinfo.gov/content/pkg/FR-2020-04-14/html/2020-07752.htm
https://www.govinfo.gov/content/pkg/FR-2020-04-14/pdf/2020-07752.pdf
2 p.
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85 FR 20693
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV; Guidance for Industry; Availability; Federal Register Vol. 85, Issue
NOTICE
2020-07752
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2018-D-4662
4164-01-P
2020-07752
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #259 entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV'' (VICH GL58). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is an annex to the VICH parent stability guidance, GFI #73 (VICH GL3(R)), ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision),'' and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration or application submitted within the regions in climatic zones III and IV.
The announcement of the guidance is published in the Federal Register on April 14, 2020.
Mai Huynh, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0669, Mai.Huynh@fda.hhs.gov.
Mai.Huynh@fda.hhs.gov
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry
https://www.fda.gov/media/70241/download
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 85, no. 72
Office of the Federal Register, National Archives and Records Administration
2020-04-14
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