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Sponsored by Zoetis

Sponsored By Zoetis

PHTweb Antibiotic Sales Ss18100861 Cr Sr

FDA to require species-specific sales data on antibiotics used in food animals

Drug companies will have to break down their antibiotic-sales data by species in their annual reports to FDA, according to a new rule issued by the agency.

Annual FDA reporting requirements already require drug companies to provide overall estimates on the amount of antimicrobials they sell or distribute for use in food-animals, whether the drugs are used in humans or not.

Adding the species-specific requirement “will complement the data collection plan we are developing to obtain additional on-farm use and resistance data,” FDA said.

“The collection of data from multiple sources, including enhanced sales data from antimicrobial animal drug sponsors, is needed to provide a comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture,” the agency said in a statement.

“Such information will further enhance our ongoing activities related to slowing the development of antimicrobial resistance to help ensure that safe and effective antimicrobial new animal drugs will remain available for use in human and animal medicine.”


Posted on June 2, 2016

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