FDA Offers Funds for Duration of Use Studies
The U.S. Food and Drug Administration has expanded its Fiscal Year 2019 funding opportunity and is announcing a new FY 2020 funding opportunity and Request for Applications (RFA) for studies that can generate data to help establish more targeted durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals.
From March 2 to April 1, 2020, the FDA’s Center for Veterinary Medicine (CVM) will accept research applications for the FY 2020 grant program, which could fund up to $2 million to generate evidence to support the establishment of more appropriately targeted and defined durations of use for one or more of the new animal drug applications identified on the list of affected approved animal drug applications. The number of awards for this funding opportunity is contingent upon FDA funding availability and the number of suitable applications. FY 2020 grant recipients may receive a maximum of $500,000, twice the amount previously offered in FY 2019 in order allow more versatility in the range of submission types the agency is willing to accept.
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.
Additional Information from FDA:
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
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