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FDA issues guidance on reporting, mitigating animal drug shortages

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Guidance also provides examples of ways CVM may prevent or mitigate animal drug shortages and information sponsors can provide proactively to help avoid shortages.

During the COVID-19 outbreak, the U.S. Food & 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 U.S., the agency said May 7.

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 affect the 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, FDA said.

Although some supply disruptions and shortages cannot be predicted or prevented, FDA recognizes that early communication and detailed notifications from sponsors to the agency play a significant role in decreasing their incidence, impact and duration.

FDA noted that the new guidance aligns with similar agency recommendations released in March for sponsors of human drugs and biologics.

FDA said this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the U.S. Department of Health & Human Services on Jan. 31 (renewed on April 21), including any further renewals made by the HHS secretary in accordance with section 319(a)(2) of the Public Health Service Act.

For additional information, see:

Guidance for Industry #271: Reporting & Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency;

Animal Drug Shortages, and

Animal Health & Safety & the Coronavirus Disease 2019 (COVID-19).

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