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July 2, 2002

GUIDANCE ON EQUINE, PORCINE, AND CANINE ANTHELMINTIC EFFECTIVENESS AVAILABLE

The Food and Drug Administration (FDA) is announcing the availability of three final guidances for industry entitled "Effectiveness of Anthelmintics: Specific Recommendations for Equine" (VICH GL #15, FDA/CVM Guidance # 109), "Effectiveness of Anthelmintics: Specific Recommendations for Porcine" (VICH GL#16, FDA/CVM Guidance #110), and "Effectiveness of Anthelmintics: Specific Recommendations for Canine" (VICH GL#19, FDA/CVM Guidance # 111.)"

These related guidance documents been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). They are intended to standardize and simplify methods used in the evaluation of new anthelmintics submitted for approval to the European Union, Japan, and the United States.

In recent years, regulatory authorities and industry associations have undertaken many important initiatives to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce the differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products.

FDA published the notice of availability of these VICH draft guidances, giving interested persons until December 18, 2000, to submit comments. FDA received no comments. The final guidance was submitted to the VICH Steering Committee. At a meeting held on June 28, 2001, the VICH Steering Committee endorsed the three final guidances for industry.

Guidance documents 109, 110, and 111 are posted on the FDA/Center for Veterinary Medicine Home Page. 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. Please send a self-addressed adhesive label to assist in processing your request.

Written comments on final guidances may be submitted at any time to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Electronic comments may be submitted. Comments should be identified with the full title of the guidance document and Docket number 00D-1532.

Additional information on the guidance documents may be found in the June 27, 2002, Federal Register and from Dr. Thomas Letonja, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-7576, e-mail: tletonja@cvm.fda.gov.

To help clarify the numbers assigned to these guidance documents, the chart below lists the titles of the VICH guidance documents related to the effectiveness of anthelmintics, and includes the FDA/Center for Veterinary Medicine (CVM) numbers and the VICH numbers.

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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