FDA In Brief: FDA Issues Four Draft Guidances To Help Facilitate the Development of New Animal Drug Products

SILVER SPRING, Md., July 14, 2020 /PRNewswire/ -- The following quote is attributed to Steven M. Solomon, D.V.M., M.P.H., director of the FDA's Center for Veterinary Medicine:

"We are committed to working with animal drug sponsors to ensure our review and approval process for new animal drugs is as efficient as possible, and we welcome the opportunity to meet with animal drug sponsors to discuss innovative approaches to developing the data needed to support an approval and ultimately help safe and effective animal drugs reach the marketplace."

"Today's action fulfills part of the FDA's Animal Drug and Animal Generic Drug User Fee Amendments of 2018 to issue guidance that assists animal drug manufacturers in addressing the incorporation of alternative approaches into proposed clinical investigation protocols and applications for new animal drugs. If finalized, the draft guidances the FDA issued today will help encourage animal drug sponsors to use innovative approaches as they prepare data submissions for new animal drug products for agency evaluation and review, as part of the FDA's new animal drug approval process."

"Congress also directed the FDA to hold a public meeting to discuss innovative animal drug investigation designs, which the FDA conducted last summer and during which the public provided comments on a variety of topics, including incorporating complex adaptive and other novel investigation designs, data from foreign countries, real-world evidence, biomarkers and surrogate endpoints into proposed clinical investigation protocols and applications for new animal drugs. The draft guidances incorporate feedback that the FDA collected during the public meeting and from comments submitted during the public comment period, which closed on September 16, 2019." 

Additional Information:

• Today, the U.S. Food and Drug Administration issued four draft guidances that, if finalized, will provide recommendations to animal drug sponsors as they prepare data submissions related to new animal drug products as part of the agency's new animal drug approval process.
• The recommendations in these draft guidance documents align with those already issued by the FDA's other medical product centers.
• GFI #265, "Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs," provides draft guidance on how to incorporate data from foreign countries to support the demonstration of effectiveness of new animal drugs and how to obtain feedback from the Center for Veterinary Medicine (CVM) regarding study protocols for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• GFI #266, "Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs," provides draft guidance on how sponsors can incorporate real-world data and real-world evidence (including ongoing surveillance activities, observational studies and registry data) into proposed clinical investigation protocols and applications for new animal drugs under the FD&C Act. The draft guidance also explains how CVM intends to evaluate real-world data and real-world evidence in submissions to demonstrate effectiveness of new animal drugs, and how to obtain feedback from CVM before an application submission.
• GFI #267, "Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs," provides draft guidance on how CVM intends to evaluate biomarkers, including surrogate endpoints, to determine whether they may be used to support the effectiveness of new animal drugs under the FD&C Act, as well as how to obtain feedback from CVM on technical issues related to the use of biomarkers before an application submission.
• GFI #268, "Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs," provides draft guidance on how sponsors can use complex, adaptive and other novel investigation designs to support the effectiveness of new animal drugs, and how to obtain feedback from CVM on how to incorporate adaptive design features into proposed investigation and study protocols for new animal drugs.
• Although the public may submit comments on any FDA guidance document at any time, we suggest you submit comment(s) on the draft guidances within 90 days to ensure that the FDA considers your comment(s) before it begins work on the final version of the guidance documents.

Additional Resources:

• FDA issues draft guidances to assist industry with the development of new animal drug submissions
• GFI #265, "Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs"
• GFI #266, "Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs"
• GFI #267, "Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs"
• GFI #268, "Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs"

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration