November 29, 2006
Spanish Translations of Three Guidance for Industry Documents Related to VICH Posted on the CVM Website
The FDA's Center for Veterinary Medicine (CVM) is actively involved in the international harmonization of requirements for the approval of veterinary drugs through participation in the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) (http://www.vichsec.org/). The finalized VICH guidelines have been implemented as CVM guidance documents and posted in the CVM website in English. CVM has recently posted on its website Spanish translations of three guidance for industry documents on safety studies for residues of veterinary drugs in human food at: http://www.fda.gov/cvm/CVMEspanol.htm. CVM intends to translate all finalized VICH guidelines as implemented by FDA to make the guidance documents more widely available.
Below are the English and Spanish titles for the translated guidance documents:
Guidance for Industry 115: Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies - VICH GL22 - Final Guidance, July 27, 2006 | html | | pdf |
Guidance for Industry 116: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing - VICH GL23 - Final Guidance, July 26, 2006 | html | | pdf |
Guidance for Industry 149: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing -VICH GL33 - - Final Guidance, July 26, 2006 | html | pdf |
Guía para la Industria 115 - Estudios para Evaluar la Seguridad de Residuos de Medicamentos Veterinarios en Alimentos Humanos: Estudios de Toxicidad Reproductiva - VICH GL22 - Guia Final, Julio 27, 2006 | doc | | pdf | | html |
Guía para la Industria 116 - Estudios para Evaluar la Seguridad de Residuos de Medicamentos Veterinarios en Alimentos Humanos: Estudios de Toxicidad Genética - VICH GL23 - Guia Final, Julio 27, 2006 | doc | | pdf | | html |
Guía para la Industria 149 - Estudios para Evaluar la Seguridad de Residuos de Medicamentos Veterinarios en Alimentos para Humanos: Enfoque General de los Estudios - VICH GL33 - Guia Final, Julio 27, 2006 | doc | | pdf | | html |
Any questions about the Spanish translations of these documents may be directed to Dr. Haydee Fernandez, 301-827-6981, Haydee.Fernandez@FDA.HHS.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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