The FDA Issues Final Guidance on Electronic Adverse Event Reporting for Animal Drugs - Business Solutions for Equine Practitioners | EquiManagement

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

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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.

Additional information can be found at http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm426072.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.