Medmarc Blog (blog.medmarc.com)
An Overview of Liability Immunity for Products Meant to Counter COVID-19 Under the PREP Act
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
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...
FY 2021 Budget Proposal Hits NIH, Mostly Flat for FDA
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...
FDA Inks Combo Product Feedback Guidance
The FDA and industry have been at loggerheads over various issues surrounding combination products, but a new draft guidance may help resolve some of those conflicts.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...