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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...

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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

Gardner Law on

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

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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

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 1, January 2023

Spilman Thomas & Battle, PLLC on

Big Boosts to Cybersecurity and Tech Funding in $1.7T Omnibus Bill Signed by Biden - “The bipartisan fiscal 2023 omnibus spending agreement includes $2.9 billion for the Cybersecurity and Infrastructure Security Agency, a...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - January 2023

Shook, Hardy & Bacon L.L.P. on

LEGISLATION, REGULATIONS & STANDARDS - Omnibus Spending Bill Includes Congressional Notes to FDA - President Biden has signed a spending bill that includes additional funding for the U.S. Food and Drug Administration (FDA)...more

Husch Blackwell LLP

CMS To Issue Interim Rule Imposing Vaccine Mandate For Healthcare Settings

Husch Blackwell LLP on

Husch highlights •On September 9, 2021, President Biden announced a new vaccine mandate for healthcare workers employed at most Medicare- and Medicaid-certified facilities; continued participation in Medicare and Medicaid...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

Faegre Drinker Biddle & Reath LLP

FDA Funding Opportunity Announcement: “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory...

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The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials...more

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