Thursday, May 7, 2020

Coronavirus (COVID-19) Update: FDA Issues Guidance on Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency

During the COVID-19 outbreak, the U.S. Food and Drug Administration continues to monitor the animal drug supply chain and work closely with animal drug sponsors, to ascertain as early as possible, any shortage or potential shortage that is likely to lead to a disruption in the availability of animal drugs or their components in the United States.

To help animal drug sponsors submit timely and informative notifications, FDA is publishing a guidance for immediate implementation about the importance of these notifications, how sponsors can notify FDA, and the details to provide about the discontinuance or interruption of manufacturing and other factors that may impact availability of animal drug products. The guidance also provides examples of steps FDA’s Center for Veterinary Medicine (CVM) may take to prevent or mitigate animal drug shortages, and information sponsors can provide proactively to help avoid shortages.

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