February 11, 2002
DRAFT GUIDANCE ON PHARMACOVIGILANCE OF VETERINARY MEDICINAL PRODUCTS AVAILABLE FOR COMMENT
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms" (#143.) This draft guidance has been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance addresses the process for developing a controlled list of terms to assure that terms are used consistently in adverse event reports and to allow comparison between products and across product classes. This draft guidance is limited to developing a controlled list of terms describing veterinary medicinal products (VMPs), animals, clinical signs, and associated body systems and organs for reporting an adverse event associated with the use of a VMP.
Draft guidance #143 is posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the draft guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800.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Written comments on the draft guidance may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted also. Comments should be identified with the full title of the draft guidance and Docket number 02D-0005. To ensure their adequate consideration in preparation of the final document, comments should be submitted by March 8, 2002. General comments on Agency guidance documents are welcome at any time.
Additional information on the draft guidance document may be found in the February 6, 2002, Federal Register and from Dr.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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