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2015-03-07
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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies; Revised Guidance for Industry; Availability
Notices
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D09002ee1c1771eeb
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (GFI #208) entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies'' (VICH GL49(R)). This revised guidance, which provides minor updates to a final guidance on the same topic for which a notice of availability was published in the Federal Register of September 15, 2011, has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised VICH guidance document is intended to provide a general description of the criteria that have been found by the European Union, Japan, United States, Australia, New Zealand, and Canada to be suitable for the validation of analytical methods used in veterinary drug residue depletion studies.
80 FR 12490
https://www.govinfo.gov/app/details/FR-2015-03-09/2015-05346
2015-05346
fr09mr15-78
4164-01-P
Docket No. FDA-2010-D-0165
https://www.govinfo.gov/app/details/FR-2015-03-09/2015-05346
https://www.govinfo.gov/content/pkg/FR-2015-03-09/html/2015-05346.htm
https://www.govinfo.gov/content/pkg/FR-2015-03-09/pdf/2015-05346.pdf
2 p.
12490
12491
80 FR 12490
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies; Revised Guidance for Industry; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-05346
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2010-D-0165
4164-01-P
2015-05346
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (GFI #208) entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies'' (VICH GL49(R)). This revised guidance, which provides minor updates to a final guidance on the same topic for which a notice of availability was published in the Federal Register of September 15, 2011, has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised VICH guidance document is intended to provide a general description of the criteria that have been found by the European Union, Japan, United States, Australia, New Zealand, and Canada to be suitable for the validation of analytical methods used in veterinary drug residue depletion studies.
Submit either electronic or written comments on Agency guidances at any time.
Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0788, julia.oriani@fda.hhs.gov.
Guidance:
Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies
,
julia.oriani@fda.hhs.gov
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm
http://www.regulations.gov
www.regulations.gov
Federal Register
Vol. 80, no. 45
Office of the Federal Register, National Archives and Records Administration
2015-03-09
continuing
daily
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245 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
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DGPO
2015-03-07
2023-10-12
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FR
FR-2015-03-09
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