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Pharmacovigilance of Veterinary Medicinal Products Guidance

06/21/2007

Federal Register Notice: FDA is making available for comments, Revised Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (VICH GL30). This revised draft guidance, which updates a draft guidance on the same topic, has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The document describes the specific data elements to be used for the submission and exchange of spontaneous adverse event reports between marketing authorization holders and regulatory authorities. To download this guidance, click here. To view this notice, click here.

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