December 13, 2001
DRAFT GUIDANCE ON PHARMACOVIGILANCE OF VETERINARY MEDICAL PRODUCTS AVAILABLE FOR COMMENT
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#142) entitled "Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)." This draft guidance has been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). It is intended to describe the reporting system for identification of possible adverse events following the use of marketed veterinary medicinal products submitted to the European Union, Japan, and the United States.
Draft guidance #142 is available on the FDA/Center for Veterinary Medicine (CVM) Home Page on the Internet. Single copies of the guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800. Please send one self-addressed adhesive label to assist in processing your request.
Written or electronic comments on this draft guidance should be submitted by January 14, 2002, to ensure their adequate consideration in preparation of the final document. General comments on Agency guidance documents are welcome at any time. Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments should be submitted to: http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm. Comments should be identified with the full title of the draft guidance and Docket number 01D-0501.
Additional information about this draft guidance document may be found in the December 13, 2001, Federal Register, and from Dr. William C. Keller, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6642.
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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