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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Requests Comments On Good Clinical Practices Guidance Document

August 11, 1999

FDA's Center for Veterinary Medicine announced the availability for comment of a draft guidance document entitled: "Guidance for Industry, Good Clinical Practices Draft Guidance" (#85) in the August 3, 1999 Federal Register. This draft guidance document was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).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Copies of this draft guidance document may be obtained from our Guidelines and Guidances Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine,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Interested persons may submit written comments on the draft guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, by September 2, 1999. Comments should be identified with the full title of the draft guidance document and docket number 99D-2406.

Further information about this document is contained in the August 3, 1999, Federal Register notice. Information on the final guidance document is also available 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.

 

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