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Guidance on Veterinary Controlled List of Terms

10/09/2014

Federal Register Notice: FDA is making available a document: Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (VICH GL30). It has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. Its purpose is to describe the controlled lists of terms critical to completing the controlled data fields as identified in the guidance entitled Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine. To download the VICH guidance, click here. To view this notice, click here.

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