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A Look Ahead at the Biden Administration’s Regulatory and Enforcement Priorities [Video]

With the new administration poised to take office, public and private companies will need to consider how President Biden’s regulatory, enforcement, and legislative priorities will affect their businesses. During this...more

FDA Announces Planned Changes to the 510(k) Premarket Notification Program

Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices. Background - On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more

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