FDA Offers Funding for Duration-of-Use Studies
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 3, 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. This important work helps to preserve the effectiveness of these antimicrobials in both veterinary and human medicine and is one of the actions highlighted in CVM’s five-year plan for supporting antimicrobial stewardship in veterinary settings.
Updating the dosage regimens of the affected approved animal drug products is a significant scientific and technical challenge. Changes to the use conditions of these products will be based on science and available evidence, and the FDA believes this RFA will help generate such information.
As the FDA continues to develop an approach for defining targeted durations of use, the agency remains committed to engaging and seeking input from a variety of stakeholders.
See additional Information on FDA’s efforts to support judicious use of antimicrobials in food animals.
List of Approved Medically Important Antimicrobial Drugs Administered in the Feed of Food-Producing Animals that Lack a Defined Duration of Use
Funding Opportunity Announcement: Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals
FDA - Judicious Use of Antimicrobials