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Life Sciences › Department of Justice (DOJ) › Civil Monetary Penalty

Parker Poe Adams & Bernstein LLP

Is FDA's Civil Money Penalty Authority Dead, and If So, What Does It Mean for Life Sciences Companies?

Parker Poe Adams & Bernstein LLP on

Does the recent decision in a federal district court in Texas, finding that the U.S. Food and Drug Administration’s tobacco civil money penalty authority is unconstitutional, mean the end of the federal agency bringing...more

Troutman Pepper Locke

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

Troutman Pepper Locke on

In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

Troutman Pepper Locke

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

Troutman Pepper Locke on

The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more

Paul Hastings LLP

New OIG Developments Provide Additional Avenues for Feedback and Compliance Guidance

Paul Hastings LLP on

In recent months, the Department of Health and Human Services, Office of Inspector General (“OIG” or “the agency”) announced two major developments in its effort to provide enhanced health care and life sciences industry...more

Skadden, Arps, Slate, Meagher & Flom LLP

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Skadden, Arps, Slate, Meagher & Flom LLP on

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement Spotlight: US Prosecutors Continue To Target Medical Technology Companies

Skadden, Arps, Slate, Meagher & Flom LLP on

Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more

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