Health Care Law News and Insights

Editor's Note: In a recent webinar, Manatt Health's Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders-including Dr. Sanjiv Shah, Chief Medical Officer of MetroPlusHealth; Kristin Wolff, Vice President, Global Policy Strategy and U.S. Government, bluebird bio; and Christine Lee, Director, Managed Care...

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In the consolidated appeal of State v. Jeannotte-Rodriguez, A-4361-19; A-4371-19; A-4374-19, the Superior Court of New Jersey, Appellate Division, addressed the State's failure to sufficiently demonstrate that a medical assistant's scope of performed services encroached upon the licensed practice of medicine. In 2018, a grand jury returned an indictment against three...

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1. APPLICABLE PRODUCT SAFETY REGULATORY REGIMES 1.1 Medical Devices The Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) are the two key statutes governing the development, manufacturing, distribution, registration, licensing, clearance and approval of such products in the USA. The U.S. Food and Drug...

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