USpolicy

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The FDA has qualified the first AI-based tool that can be used in clinical trials involving patients with MASH to help measure disease activity.

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The FDA is rolling out a pilot programme that could make it easier to bring digital health technologies for chronic diseases to market more quickly.

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CDC advisers vote to overturn decades of US policy and abandon endorsement of universal hepatitis B vaccination for newborns in the US.

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FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.

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New draft guidance from the FDA says single-target antibodies will no longer need six-month toxicity testing in animals like macaques.

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The FDA has revealed the latest element in its adoption of AI, an agentic AI platform that agency staffers can use to streamline complex tasks.