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Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Gardner Law

FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies

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In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts

Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more

Alston & Bird

Health Care Week in Review: House Passes Minibus, HHS Releases Public Inquiry on Private Equity in Health Care

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

The BIOSECURE Act and Its Potential Implications

Goodwin on

Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

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President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

Haug Partners LLP on

On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

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