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United States: FDA secures full industry engagement on antimicrobial resistance strategy

All 26 drug manufacturers affected by Guidance for Industry (GFI) #213 have now agreed to fully engage in the strategy.

Thursday 3 July 2014 (3 years 7 months 15 days ago)

The U.S. Food and Drug Administration announced the first of its progress reports on its strategy to promote the judicious use of antimicrobials in food-producing animals. All 26 drug manufacturers affected by Guidance for Industry (GFI) #213 have now agreed to fully engage in the strategy by phasing out the use of medically important antimicrobials in food-producing animals for food production purposes and phasing in the oversight of a veterinarian for the remaining therapeutic uses of such drugs.

While GFI #213 specified a three-year timeframe (until December 2016) for drug sponsors to complete the recommended changes to their antimicrobial products, some sponsors have already begun to implement them.

FDA is committed to updating the public on the progress that drug sponsors have made in aligning their products with GFI #213 and intends to do so on a six-month basis. FDA’s progress reports will summarize current and pending actions taken by sponsors to align with the guidance, including the type of action (e.g., withdrawal, change in marketing status) and, when possible without revealing confidential business information, the type of animal for which the drug is approved for use and the type of application (pioneer, generic, combination).

Monday June 30, 2014/ FDA/ United States.
http://www.fda.gov/

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