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U.S. Department of Health and Human Services

Animal & Veterinary

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FINAL GUIDANCE PUBLISHED ON VALIDATION OF ANALYTICAL PROCEDURES

FDA Veterinarian Newsletter September/October 1999 Volume XIV, No V

FDA's Center for Veterinary Medicine has published two final guidance documents for industry entitled "Validation of Analytical Procedures: Definition and Terminology" (Guidance Document #63) and "Validation of Analytical Procedures: Methodology'' (Guidance Document #64.) These guidances have been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). They will be implemented in October 1999.

Copies of these final guidance documents may be obtained from CVM's Guidelines and Guidances Page or by calling or writing the FDA Veterinarian.

Interested persons may submit written comments on the final guidance documents 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 Guidance Document #63 is contained in the July 28, 1999, Federal Register, and about Guidance Document #64 is contained in the August 4, 1999, Federal Register. Information on these final guidance documents 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.