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U.S. Department of Health and Human Services

Animal & Veterinary

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VICH DRAFT GUIDANCE DOCUMENTS AVAILABLE

FDA Veterinarian Newsletter September/October 1999 Volume XIV, No V

The Food and Drug Administration (FDA) has announced the availability of the following draft guidances for industry: "Guidance for Industry: Stability Testing for Medicated Premixes (#91)" "Guidance for Industry: Impurities In New Veterinary Drug Substances (#92)," "Guidance for Industry: Impurities In New Veterinary Medicinal Products (#93), "Guidance for Industry: Efficacy of Anthelmintics: General Recommendations (#90),'' "Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Bovines (#95)," "Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Ovines (#96)," and "Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Caprines (#97)." These draft guidance documents have been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

Copies of all these draft guidance documents may be obtained from CVM's Guidelines and Guidances Page or by calling or writing the FDA Veterinarian.

Further information on VICH is available from Dr. Sharon R. Thompson (HFV-3), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1798, e-mail: sthompso@cvm.fda.gov and from Dr. Robert C. Livingston, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, MD 20855, 301-594-5903, e-mail: rlivings@cvm.fda.gov.

Further information about draft guidance documents #91, #92, and #93 is contained in a July 22, 1999, Federal Register notice. Information on draft guidance document #91 is also available from William G. Marnane (HFV-140), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6966, e-mail wmarnane@cvm.fda.gov. Information on draft guidance documents #92 and #93 is available from Dr. Kevin J. Greenlees, Center for Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6977, e-mail kgreenle@cvm.fda.gov.

Further information about draft guidance documents #90, #95, #96, and #97 is contained in a July 16, 1999, Federal Register notice. Information on these draft guidance documents is also available from Dr. Thomas Letonja (HFV-130), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-7576, e-mail: tletonja@cvm.fda.gov.