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U.S. Department of Health and Human Services

Animal & Veterinary

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GOOD CLINICAL PRACTICES DRAFT GUIDANCE DOCUMENT AVAILABLE

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

FDA's Center for Veterinary Medicine announced the availability of a draft guidance document entitled: "Guidance for Industry, Good Clinical Practices Draft Guidance" (#85) in the August 3, 1999 Federal Register. This draft guidance document was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). It is intended to provide a unified standard as well as an international ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting clinical studies evaluating veterinary products.

Copies of this draft guidance document may be obtained from the Guidelines and Guidances Page or by calling or writing the FDA Veterinarian.

Further information about this document is contained in the August 3, 1999, Federal Register notice and from Dr. Herman M. Schoenemann (HFV-120), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0220, e-mail: hschoene@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.