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FDA 'encouraged' by industry response to Guidance 213

As of March 12, FDA has received responses from all sponsors affected by this guidance and is currently reviewing and analyzing those responses.

On Dec. 12, 2013, as part of its plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, the Food & Drug Administration asked the animal pharmaceutical industry to notify the agency in writing within 90 days of its intent to engage with FDA as defined in Guidance 213, which lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications and place therapeutic uses under veterinary oversight.

As of March 12, FDA said it has received responses from all of the sponsors affected by this guidance and is currently reviewing and analyzing those responses. The agency said it is "encouraged by the positive response thus far."

FDA said it issue a more detailed update later this month concerning the sponsors that have committed to seeking withdrawal of approval relating to production uses and changing the marketing status of their products from over-the-counter to use by Veterinary Feed Directive or prescription.

Earlier this week, members of the Animal Health Institute and the Generic Animal Drug Alliance announced their written commitments to align all affected products with the FDA policy on judicious use of antibiotics.

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