August 11, 1999
FDA REQUESTS COMMENTS ON GOOD CLINICAL PRACTICES GUIDANCE DOCUMENT
FDA's Center for Veterinary Medicine announced the availability for comment of a draft guidance document entitled: "Guidance for Industry, Good Clinical Practices Draft Guidance" (#85) in the August 3, 1999 Federal Register. This draft guidance document was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).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Copies of this draft guidance document may be obtained from our Guidelines and Guidances Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine,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Interested persons may submit written comments on the draft guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, by September 2, 1999. Comments should be identified with the full title of the draft guidance document and docket number 99D-2406.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".
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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