Zdrowie i gospodarka · 22/07/1999
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on Stability Testing for Medicated Premixes; Availability; Request for Comments
The Food and Drug Administration (FDA) is announcing the availability for comment on the following draft guidance for industry document entitled ``Stability Testing for Medicated Premixes.'' This draft guidance document has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance document is an annex to the parent guidance VICH GL3 entitled ``Stability Testing of New Drug Substances and Products in the Veterinary Field.'' This draft guidance document is the annex and addresses the recommendations for stability testing of veterinary medicinal Type A medicated articles (referred to as medicated premix drug products in the draft guidance) intended for submission for approval to the European Union, Japan, and the United States.