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Food and Drug Administration and Compliance Issues
Monday, April 1, 2019
FDA Announces Funding Opportunity to Help Define Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
The U.S. Food and Drug Administration today announced a funding opportunity and Request for Applications (RFA) for studies that can help target and define durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals. The agency also posted a list of the affected products.
From April 1 to June 1, 2019, the FDA’s Center for Veterinary Medicine (CVM) will accept research applications for the Fiscal Year (FY) 2019 program, which will fund up to $1.5 million in support of applications for studies in FY 2019, with a maximum of $250,000 provided to any individual awardee. Subject to resources and awardee performance, awardees will be eligible for an additional year of support in FY 2020 up to $250,000. The number of awards is contingent upon FDA funding availability and the number of suitable applications.
The FDA is offering funding to help generate publicly available data that sponsor(s) of affected approved animal drug applications can use to update product dosage regimens to better target when and for how long the drug may be used. Defining more targeted durations of use supports the FDA's ongoing efforts to slow the development of antimicrobial resistance by fostering the judicious use of medically important antimicrobial drugs in animals.