FDA Seeks Comments on Possible Changes to Animal Drug Sponsor Reports
The Food and Drug Administration is asking for comments on possible changes to its regulation requiring animal drug sponsors to submit reports, including periodic drug experience reports containing drug distribution data showing the amount of the drug distributed domestically and…
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the amount exported. Specifically, FDA is seeking comments on: (1) whether it should require the submission of additional sales and distribution information including an estimate of the amount of each active antimicrobial ingredient sold or distributed for use in each approved food-producing animal species; (2) how to compile and present its annual summary report of the sales and distribution data collected from sponsors of antimicrobial new animal drugs; and (3) alternative methods available to FDA for obtaining additional data and information about the extent of antimicrobial drug use in food producing animals. Comments are due by Sept. 25.