MoFo Life Sciences

April 28, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Healthcare
Mental Health during COVID-19: FDA Waivers for Digital Health Devices
By: Jean Nguyen
As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern. Last week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for treating
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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 21, 2020 - FDA, COVID-19, Product Liability + Class Action, Healthcare
HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation
By: Erin M. Bosman and Julie Y. Park
On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19. The PREP Act grants tort
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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 25, 2020 - FDA, COVID-19, Healthcare
FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked
By: Erin M. Bosman and Julie Y. Park
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based
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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 22, 2020 - United States, FDA, COVID-19, Product Liability + Class Action, Healthcare
FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus (COVID-19); State Attorneys General Follow Suit
By: Erin M. Bosman and Julie Y. Park
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) recently issued their first round of
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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
By: Keunbong (KB) Do
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 09, 2020 - FDA, COVID-19, Biotech, Pharma, Blockchain
Blockchain and The Drug Supply Chain Security Act (DSCSA)
As industry continues to grapple with and implement the Drug Supply Chain Security Act (DSCSA) enacted by Congress in 2013, some of the largest pharmaceutical companies believe they may have a solution to track prescription drugs across the supply chain to prevent the distribution
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