Health Care Law News and Insights

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...

Read More

Additional $25.5 Billion in COVID-19 Provider Funding The Department of Health and Human Services ("HHS") announced that an additional $25.5 billion in new funding will be available for health care providers affected by the COVID-19 pandemic. $8.5 billion of the funding will be allocated to the American Rescue Plan ("ARP") for providers who...

Read More

On Thursday, Sept. 9, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a press release indicating that further COVID-19 vaccination requirements are forthcoming for health care workers. The press release comes at the direction of the Biden-Harris administration, which has indicated it will issue requirements for mandatory COVID-19 vaccination of...

Read More