At next year’s Industry Overviews at VMX and WVC, we will focus on innovation in animal health. Recent developments in human health highlight efforts to accelerate innovation by streamlining regulatory processes rather than relying solely on company-driven advances.
Two notable proposals have emerged: approving human products based on a single well-designed trial instead of two and reducing user fees for early-stage companies conducting U.S. clinical trials. While the first proposal has raised concerns, many believe it could foster innovation by making approvals faster and less costly. The second proposal relates to ongoing PDUFA negotiations, with operational details still under discussion.
Encouragingly, these initiatives originate within the FDA. Human health industry groups are also contributing ideas, and our own animal health association (AHI) recently recommended regulatory reforms and process efficiencies for CVM. With ADUFA negotiations beginning next year, regulatory innovation in animal health may not be far behind
Robert Jones
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