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U.S. Department of Health and Human Services

Animal & Veterinary

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STABILITY DRAFT GUIDANCE DOCUMENTS AVAILABLE

FDA Veterinarian Newsletter September/October 1998 Volume XIII, No V

FDA is announcing the availability of three draft Guidance for Industry (GFI) documents entitled "Stability Testing of New Animal Drug Substances and Products" (#73), "Stability Testing for New Dosage Forms of New Animal Drugs" (#74), and "Stability Testing: Photostability Testing of New Animal Drug Substances and Products" (#75).

These draft documents have been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). They are intended to provide guidance on stability testing of new drug substances and products and new dosage forms included as part of registration applications for approval of veterinary medicinal products submitted for approval to the European Union, Japan, and the United States.

Copies of these documents may be obtained from CVM's Internet Home Page or by contacting the FDA Veterinarian.

In recent years, many important initiatives have been undertaken to promote the international harmonization of regulatory requirements. FDA has participated in VICH efforts to enhance harmonization and has expressed its commitment to seeking scientifically based harmonized technical requirements for the registration of pharmaceutical products. One of the goals of harmonization is to identify and reduce the differences in technical requirements for drug registration among regulatory agencies in different countries.

The draft guidance entitled "Stability Testing of New Animal Drug Substances and Products" addresses the generation of stability information that should be included in submissions for applications for registration or approval of new molecular entities and associated drug products. The guidance entitled "Stability Testing: Photostability Testing of New Animal Drug Substances and Products" sets out a basic testing protocol for photostability. "Stability Testing for New Dosage Forms of New Animal Drugs" addresses the generation of stability information for new dosage forms for submission by the owner of the original application for registration, after the original application for new drug substances and products has been submitted.

Further information about these draft guidance documents is contained in a July 30, 1998, Federal Register notice. Information on the draft guidance documents is also available from William G. Marnane, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-0678. E-mail: wmarnane@bangate.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. E-mail: sthompso@bangate.fda.gov.