October 19, 2000
DRAFT GUIDANCE ON ANTHELMINTIC EFFECTIVENESS AVAILABLE
The Food and Drug Administration (FDA) announced in the October 19, 2000, Federal Register, the availability of three draft guidances for industry entitled "Effectiveness of Anthelmintics: Specific Recommendations for Equine" (#109,) "Effectiveness of Anthelmintics: Specific Recommendations for Porcine'' (#110,) and "Effectiveness of Anthelmintics: Specific Recommendations for Canine'' (#111.) These draft guidances are available for comment only.
These draft guidance documents were developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).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.
These three draft guidances should be read in conjunction with the "Efficacy of Anthelmintics: General Recommendations (EAGR)'' announced in the Federal Register of July 16, 1999. The draft guidances for equine, porcine, and canine are part of the EAGR, and the aim of these three draft guidances is to: (1) Be more specific for certain issues not discussed in the general guidance, (2) highlight differences with the EAGR on effectiveness data recommendations, and (3) give explanations for disparities with the EAGR.
These draft guidances represent current FDA thinking on effectiveness recommendation for certain veterinary anthelmintic medicinal products. These draft guidances do not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternate method may be used as long as it satisfies the requirements of applicable statutes and regulations.
Copies of these documents may be obtained from CVM's 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 guidance documents to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with the full title of the guidance document and with Docket number 00D-1532. Comments should be submitted by December 18, 2000 to ensure their adequate consideration in preparation of the final guidance document. General comments on Agency guidance documents are welcome at any time.
Further information about these guidance documents is contained in the October 19 Federal Register. Information on the guidance documents is also available from Dr. Thomas Letonja, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-7576, Information regarding the VICH is available from: Dr. Sharon R. Thompson, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1798 or Mrs. Carole R. Andres, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6524.
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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