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The U.S. Food and Drug Administration’s Center for Veterinary Medicine plays a vital role in facilitating the development and availability of innovative medical products for animals. Our role in promoting public health drives us to take steps that can help facilitate access to safe, effective, and innovative products to address existing, new, and emerging animal health challenges. The FDA takes a proactive approach, using all of our available tools and flexible processes, to provide timely and efficient review approaches to ensure safety and effectiveness and help bring these innovations to the market.
Today the FDA released four final guidance documents that demonstrate our commitment to innovative approaches. The guidance documents describe pathways for animal drug sponsors to use new approaches like adaptive study designs, real world evidence and biomarkers to establish drug effectiveness and more detailed guidance on how to leverage data collected from foreign countries to support approval of their products in the U.S. These guidance documents encourage animal drug sponsors to consider these innovative approaches as they prepare data submissions related to new animal drug products for agency evaluation and review, as part of the FDA’s new animal drug approval process. The recommendations in these guidance documents closely align with those already issued by the FDA’s other medical product centers.
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