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Medmarc Blog (blog.medmarc.com)

An Overview of Liability Immunity for Products Meant to Counter COVID-19 Under the PREP Act

March 27, 2020

Device manufacturers (as well as drug manufacturers, distributors, and health care providers) are struggling to answer many questions regarding their potential products liability in responding...

Pandemics and Force-Majeure Clauses

March 27, 2020

With the Coronavirus (COVID-19) pandemic, medical device companies are facing disruptions to their supply chains, vendors who simply stop providing services, and a denuded work force. Who is...

Congress Sets Aside $8.3 Billion for Coronavirus

March 20, 2020

The U.S. federal government’s response to the COVID-19 outbreak has been criticized in some quarters as laggardly, but Congress sent a supplemental spending package to the White House in early...

FY 2021 Budget Proposal Hits NIH, Mostly Flat for FDA

February 10, 2020

The Trump administration’s budget proposal for fiscal 2021 in large part reflected the administration’s past proposals for various agencies at the Department of Health and Human Services. While...

Coronavirus Prompting Reaction in Washington

February 10, 2020

The newest mutation to the coronavirus has had a massive impact in China and has prompted a reaction from the World Health Organization (WHO). The impact on makers of devices and diagnostics has...

FDA Inks Combo Product Feedback Guidance

January 29, 2020

The FDA and industry have been at loggerheads over various issues surrounding combination products, but a new draft guidance may help resolve some of those conflicts. The draft deals with...