September 15, 2002

 
​take notice

 Final guidance on anthelmintics use available - September 15, 2002

Posted on September 1, 2002


The Food and Drug Administration has issued three final guidance documents regarding the use of anthelmintics in three types of animals. These drugs expel or destroy parasitic worms, especially of the intestine.

The three documents are "Effectiveness of Anthelmintics: Specific Recommendations for Equine," "Effectiveness of Anthelmintics: Specific Recommendations for Porcine," and "Effectiveness of Anthelmintics: Specific Recommendations for Canine."

The International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products developed the documents. 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.

The three new documents join a slew of others that have been developed by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements.

The guidance documents are available at www.fda.gov/cvm. Individuals can also obtain them by writing to the Communications Staff, FDA Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855. Include a self-addressed adhesive label when requesting a document by mail.

Additional information on the guidance documents may be obtained from Dr. Thomas Letonja at the FDA Center for Veterinary Medicine (HFV-135), 7500 Standish Place, Rockville, MD 20855; phone, (301) 827-7576; or tletonja@cvm.fda.gov. Information can also be found in the June 27, 2002, Federal Register at www.fda.gov/OHRMS/DOCKETS/98fr/062702j.htm.

Written comments about the 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.