News & Analysis as of

Medical Research Enforcement

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

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Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

Health Care Compliance Association (HCCA)

Final Rule Increases Fines for Grant Fraud, Codifies OIG Authority to Sanction Awardees

Report on Research Compliance Volume 20, no 8 (August 2023) With the publication of a rule finalizing financial penalties for grant fraud and related violations of U.S. law, the HHS Office of Inspector General (OIG) has a...more

Vinson & Elkins LLP

Data Corruption: DOJ Targets Fraud In Medical Research Trial In The Era Of COVID-19

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In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more

Faegre Drinker Biddle & Reath LLP

If You Think You’re Safe from FDA Scrutiny Because You’re in an Ivory Tower, Think Again

FDA increases enforcement based on clinical research violations. According to recently-posted data, 2014 was a banner year for FDA enforcement based on clinical research violations. ...more

Holland & Knight LLP

CMS Issues Final Physician Payment Sunshine Rule

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In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on February 1, the Centers for Medicare and Medicaid Services (CMS) publicly...more

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