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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: Methodology

August 11, 1999

In the August 4, 1999, Federal Register, FDA's Center for Veterinary Medicine announced the publication of final guidance for industry entitled "Validation of Analytical Procedures: Methodology" (Guidance Document #64.) The guidance provides recommendations on how to consider various validation characteristics for each analytical procedure included as part of registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. This guidance will be implemented in October 1999.

Copies of this final guidance document may be obtained from our 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 August 4, 1999, Federal Register notice. Information on the final guidance document is also available from William G. Marnane, Center for Veterinary Medicine (HFV-140), 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.

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855