International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General Recommendations (Revision 1); Draft Guidance for Industry; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #90 (VICH GL7(R1)) entitled "Effectiveness of Anthelmintics: General Recommendations (Revision 1)." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this draft guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/ regional requirements for anthelmintic drugs in animal species. This revision updates data analysis and isolate characterization recommendations, outlines how to approach new indications, and makes additional clarifying changes.
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