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FDA to fund duration of use studies

One project to generate data on use of tylosin phosphate to prevent liver abscesses in feedlot cattle; second project will evaluate timing of chlortetracycline treatment of bovine anaplasmosis.

The U.S. Food & Drug Administration announced Sept. 27 that it has awarded two $250,000 grants to fund research projects in fiscal 2019 aimed at helping target and define durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals.

Defining targeted durations of use is one component of FDA’s five-year plan, "Supporting Antimicrobial Stewardship in Veterinary Settings," published last September, that outlines key goals and objectives for fiscal years 2019-23.

These research projects will generate publicly available data that can be used by sponsors of affected approved animal drug applications to update product dosage regimens and better target when and for how long a drug may be used, FDA said.

According to the announcement, the first project is from a researcher at Kansas State University and sets out to define targeted durations of use for tylosin phosphate to prevent liver abscess formation in feedlot cattle.

The second project, from another researcher at Kansas State, plans to evaluate the timing and duration of use for chlortetracycline treatment of bovine anaplasmosis in adult cattle, FDA said.

Depending on available funding and satisfactory progress by the awardees, FDA said it may grant an additional year of support of up to $250,000 each for the researchers to continue their studies in fiscal 2020.

In addition, FDA said it continues to explore options for expanding the availability of relevant data to address this issue, including the possibility of providing another funding opportunity for research proposals.

Source: Food & Drug Administration, which is solely responsible for the information provided and is wholly owned by the source. Informa Business Media and all its subsidiaries are not responsible for any of the content contained in this information asset.
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