Zdrowie i gospodarka · 06/02/2002

FDA Releases Draft Guidance on Pharmacovigilance of Veterinary Medicinal Products

The Food and Drug Administration (FDA) has released a draft guidance for industry (VICH GL30) on pharmacovigilance of veterinary medicinal products, which outlines the process for developing a controlled list of terms to ensure consistent use in adverse event reports. The draft guidance, developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), aims to standardize terminology for reporting adverse events associated with veterinary medicinal products.