August 3, 1999
FINAL GUIDANCE PUBLISHED ON VALIDATION OF ANALYTICAL PROCEDURES
In the July 28, 1999 Federal Register, FDA's Center for Veterinary Medicine announced the publication of final guidance for industry entitled "Validation of Analytical Procedures: Definition and Terminology" (Guidance Document #63.) This guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The document provides guidance on characteristics that should be considered during the validation of analytical procedures included as part of registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. The final guidance will be implemented in October 1999.
Copies of this final guidance document may be obtained from CVM's Guidelines and Guidances Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.
Interested persons may submit written comments on the final guidance document to the Policy and Regulations Team (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855.
Further information about this document is contained in the July 28, 1999, Federal Register notice. Information on the final guidance document is also available from William G. Marnane (HFV-140), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6966, e-mail "wmarnane@cvm.fda.gov". Further information on VICH is available from Dr. Sharon R. Thompson (HFV-3), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1798, e-mail: "sthompso@cvm.fda.gov'' and from Dr. Robert C. Livingston, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, MD 20855, 301-594-5903, e-mail: "rlivings@cvm.fda.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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