The FDA Issues Final Guidance on Electronic Adverse Event Reporting for Animal Drugs

The U.S. Food and Drug Administration has issued final guidance #214, Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data. The guidance provides recommendations to help animal drug manufacturers create a single electronic adverse event message that can be used by multiple regulatory authorities.

The need for drug manufacturers and regulatory bodies to exchange and send information on a worldwide scope is essential to monitoring potential health risks and ensuring drug safety. The guidance, which is the FDA’s version of VICH GL35, provides a standardized format of the electronic report order to allow for electronic exchange of information between stakeholders.

GFI #214 supports the FDA’s work with the Veterinary International Conference on Harmonization (VICH), an international program aimed at harmonizing technical requirements for veterinary product regulation.

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