Medmarc Blog (blog.medmarc.com) (15)

FDA, COVID 19, Regulatory and Compliance

FDA Reacts to Coronavirus as Stimulus Bill Passes

March 30, 2020

The FDA is scrambling to meet the demands imposed by the COVID-19 outbreak, including a series of guidances dealing with a variety of issues. However, the predicament has also prompted two pieces...

3 minute read

COVID 19, Medical Device Manufacturers, Pharmaceuticals, PREP Act

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...

3 minute read

COVID 19, Medical Device Manufacturers

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...

3 minute read

COVID 19

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...

3 minute read

FDA, Health and Human Services (HHS)

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...

2 minute read

COVID 19

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...

2 minute read

FDA, Draft Guidance, Regulatory and Compliance

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The FDA and industry have been at loggerheads over various issues surrounding combination products, but a new draft guidance may help resolve some of those conflicts.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

2 minute read

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FDA Reacts to Coronavirus as Stimulus Bill Passes

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

Pandemics and Force-Majeure Clauses

Congress Sets Aside $8.3 Billion for Coronavirus

FY 2021 Budget Proposal Hits NIH, Mostly Flat for FDA

Coronavirus Prompting Reaction in Washington

FDA Inks Combo Product Feedback Guidance