October 27, 1999
DRAFT AND FINAL VICH GUIDANCE DOCUMENTS AVAILABLE
In the October 12, 1999, Federal Register, the Food and Drug Administration (FDA) announced the availability of three final Guidance for Industry (GFI) documents entitled "Stability Testing of New Veterinary Drug Substances and Medicinal Products" (# 73), "Stability Testing of New Veterinary Dosage Forms'' (#74), and "Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products'' (#75). In the same Federal Register, FDA announced the availability of two draft GFI documents entitled "Quality of Biotechnological Products in the Veterinary Field: Stability Testing of Biotechnological/Biological Products" (#99) and "Impurities: Residual Solvents" (#100).
These documents have been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) from guidances regarding pharmaceuticals for human use, which were adopted by the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use. Copies of these final and draft 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.
Draft guidances #99 ("Quality of Biotechnological Products in the Veterinary Field: Stability Testing of Biotechnological/Biological Products") and #100 ("Impurities: Residual Solvents") are intended to provide guidance to applicants on the data that should be provided in support of new animal drug applications in the U.S. as well as to help provide consistency in data required to support approval in both the European Union, Japan, and the U.S.
Written comments on draft guidance documents #99 and #100 should be submitted by November 12, 1999, to the Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane,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 Comments should be identified with the full title of the draft guidance and docket number 99D-4070 for "Quality of Biotechnological Products in the Veterinary Field: Stability Testing of Biotechnological/Biological Products" (#99) and 99D-4071 for "Impurities: Residual Solvents" (#100).
Further information about the final and draft guidance documents is contained in the October 12, 1999, Federal Register notice. Information on the three final guidance documents (#73, #74, and #75) and draft guidance document #99 is also available from William G. Marnane, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6966. E-mail: mailto:wmarnane@bangate.fda.gov. Additional information regarding draft guidance #100 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 on VICH is available from Dr. Sharon Thompson, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1798 or from Dr. Robert Livingston, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-5903.
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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