MoFo Life Sciences

April 22, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
FDA Uses EUAs Broadly In The Fight Against Covid-19
By: Julie Y. Park
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel
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April 09, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
CARES Act of 2020: Guide for Drug and Device Companies
The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward. The
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March 31, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Healthcare
FDA Inspires Modifications and Quick Authorizations for Ventilators
By: Erin M. Bosman and Julie Y. Park
As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators. Read our Class
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March 24, 2020 - FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action
Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis
By: Erin M. Bosman and Julie Y. Park
COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical
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March 18, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Biotech, Healthcare, Pharma
FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers
On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health
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March 11, 2020 - United States, Medical Devices + Diagnostics, COVID-19, Biotech, Healthcare, Pharma
U.S. government announces new federal funding opportunities related to COVID-19
By: Tina D. Reynolds
The Biomedical Advanced Research and Development Authority ( BARDA ), part of the U.S Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, has modified an existing broad agency announcement (BAA) through which it will award government funding
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January 21, 2020 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Healthcare
Digital Health in 2019
The year 2019 saw relatively few developments in the digital health space. Although progress has been slow, FDA did make headway on two initiatives: (1) addressing the unique challenges of regulating artificial intelligence and machine learning (AI/ML) in medical applications, and (2) implementing changes
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January 10, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 3)
Our earlier posts ( part 1 and part 2 ) looked at a few overall trends at FDA as well as the impact of consent decrees issued in 2019. Today we will highlight some enforcement trends at the Department of Justice. Department of Justice
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January 09, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 2)
Yesterday , we covered some 2019 stats regarding FDA’s inspections and Warning Letters, and discussed a few specific trends we saw last year. In Part Two of our series, we look at the specifics of FDA’s 2019 consent decrees. FDA Consent Decrees FDA published
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January 08, 2020 - United States, FDA, Medical Devices + Diagnostics, Litigation, Biotech, Healthcare, Pharma, Regulatory
2019 FDA Enforcement and Related Litigation Trends (Part 1)
The year 2019 was one of uncertainty for FDA, as former Commissioner Scott Gottlieb announced his departure in March, ultimately stepping down in April. For the bulk of the year, FDA was led by Acting Commissioner, Ned Sharpless, until Brett Giroir took over in
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Topic Archives: Medical Devices + Diagnostics

FDA Uses EUAs Broadly In The Fight Against Covid-19

By: Julie Y. Park

CARES Act of 2020: Guide for Drug and Device Companies

FDA Inspires Modifications and Quick Authorizations for Ventilators

By: Erin M. Bosman and Julie Y. Park

Prep Act Declaration Emboldens Drug and Device Industry to Innovate In the Face Of a Growing Crisis

By: Erin M. Bosman and Julie Y. Park

FDA’s New Guidance on Use and Distribution of COVID-19 Diagnostic Tests by Laboratories and Commercial Manufacturers

U.S. government announces new federal funding opportunities related to COVID-19

By: Tina D. Reynolds

Digital Health in 2019

2019 FDA Enforcement and Related Litigation Trends (Part 3)

2019 FDA Enforcement and Related Litigation Trends (Part 2)

2019 FDA Enforcement and Related Litigation Trends (Part 1)