Tuesday, July 14, 2020

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

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.”

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