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2010-09-23
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International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing (VICH GL32); Availability; Request for Comments
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The Food and Drug Administration (FDA) is announcing the availability for comment of a draft guidance document for industry (<greek-i>148) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing'' (VICH GL32). This draft guidance document has been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance document provides harmonized guidance on the core recommendation for a developmental toxicity study for the safety evaluation of veterinary drug residues in human food.
67 FR 56572
https://www.govinfo.gov/app/details/FR-2002-09-04/02-22407
02-22407
fr04se02-84
4160-01-S
Docket No. 02D-0369
https://www.govinfo.gov/app/details/FR-2002-09-04/02-22407
https://www.govinfo.gov/content/pkg/FR-2002-09-04/html/02-22407.htm
https://www.govinfo.gov/content/pkg/FR-2002-09-04/pdf/02-22407.pdf
2 p.
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67 FR 56572
International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing (VICH GL32); Availability; Request for Comments; Federal Register Vol. 67, Issue
NOTICE
02-22407
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2002-10-04
Docket No. 02D-0369
4160-01-S
02-22407
Notice; request for comments.
The Food and Drug Administration (FDA) is announcing the availability for comment of a draft guidance document for industry (<greek-i>148) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing'' (VICH GL32). This draft guidance document has been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance document provides harmonized guidance on the core recommendation for a developmental toxicity study for the safety evaluation of veterinary drug residues in human food.
Submit written or electronic comments on the draft guidance document by October 4, 2002 to ensure their adequate consideration in preparation of the final guidance document. General comments on agency guidance documents are welcome at any time.
Louis T. Mulligan, Center for Veterinary Medicine (HFV153), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018276984, e-mail: lmulliga@cvm.fda.gov.
Reports and guidance documents; availability, etc.:
Veterinary Medicinal Products, International Cooperation on Harmonisation of Technical Requirements for Approval
Veterinary drug residues in human food; safety evaluation studies; developmental toxicity testing,
lmulliga@cvm.fda.gov
http://www.fda.gov/cvm
http://www.fda.gov/dockets/ecomments
Federal Register
Vol. 67, no. 171
Office of the Federal Register, National Archives and Records Administration
2002-09-04
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277 p.
Table of Contents:
AE 2.7:
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https://www.govinfo.gov/content/pkg/FR-2002-09-04/pdf/FR-2002-09-04.pdf
https://www.govinfo.gov/content/pkg/FR-2002-09-04/xml/FR-2002-09-04.xml
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