MoFo Life Sciences

June 08, 2020 - FDA, COVID-19, Product Liability + Class Action
How FDA Is Monitoring the COVID-19 Product Market
By: Erin M. Bosman and Julie Y. Park
FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products, including drugs, test kits, and PPE sold online with unproven claims. It is working
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May 26, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Healthcare
FDA Signals Flexibility with COVID-19 Tests
By: Erin M. Bosman and Julie Y. Park
A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps
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May 22, 2020 - COVID-19, CFIUS, Healthcare, Asia
Japan Moves to Tighten Restrictions on Foreign Investment in Healthcare Industries
By: Gary Mitchel Smith
Amid concerns about predatory acquisitions of weakened companies and strategic assets during the COVID‑19 crisis, more and more countries are restricting foreign direct investment (FDI) in their domestic companies, especially in the medical and healthcare industries. These restrictions tend to target Chinese investment in
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May 14, 2020 - United States, FDA, COVID-19, Intellectual Property
Free Prioritized Examination for COVID-19 Patent Applications
By: Sejin Ahn and Desmond P. O'Sullivan
The United States Patent and Trademark Office (USPTO) announced a Prioritized Examination Pilot Program for COVID-19-related patent applications. To qualify, an applicant must be a small entity or micro-entity and the application must contain at least one claim covering products or process that are
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May 08, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action
COVID-19 Alert: FDA updates antibody test policy
By: Erin M. Bosman and Julie Y. Park
Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been
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May 06, 2020 - United States, COVID-19, United Kingdom, European Union, Intellectual Property
Patent Offices Extend Certain Deadlines, but Proceed With Caution
By: Desmond P. O'Sullivan
Patent applicants facing a funds shortage because of COVID-19 may be glad to hear that many patent offices have extended certain patent prosecution deadlines. For example, the U.S. Patent Office has extended various patent deadlines until June 1, 2020 and the European Patent Office
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May 01, 2020 - United States, FDA, COVID-19, Product Liability + Class Action
COVID-19 UPDATE: FDA AUTHORIZES FIRST AT-HOME COLLECTION KIT
By: Erin M. Bosman and Julie Y. Park
FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more
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May 01, 2020 - COVID-19, Asia
COVID-19: Excusing Performance Using Force Majeure Clauses Under Japanese Law
By: Chie Yakura and Yukihiro Terazawa
On April 7, 2020, Prime Minister Shinzo Abe declared a state of emergency in response to the spread of COVID19. As a result, an increasing number of businesses are unable to continue operating and are having difficulty performing their contractual obligations. Their business partners
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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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Topic Archives: All Topics

How FDA Is Monitoring the COVID-19 Product Market

By: Erin M. Bosman and Julie Y. Park

FDA Signals Flexibility with COVID-19 Tests

By: Erin M. Bosman and Julie Y. Park

Japan Moves to Tighten Restrictions on Foreign Investment in Healthcare Industries

By: Gary Mitchel Smith

Free Prioritized Examination for COVID-19 Patent Applications

By: Sejin Ahn and Desmond P. O'Sullivan

COVID-19 Alert: FDA updates antibody test policy

By: Erin M. Bosman and Julie Y. Park

Patent Offices Extend Certain Deadlines, but Proceed With Caution

By: Desmond P. O'Sullivan

COVID-19 UPDATE: FDA AUTHORIZES FIRST AT-HOME COLLECTION KIT

By: Erin M. Bosman and Julie Y. Park

COVID-19: Excusing Performance Using Force Majeure Clauses Under Japanese Law

By: Chie Yakura and Yukihiro Terazawa

Mental Health during COVID-19: FDA Waivers for Digital Health Devices

By: Jean Nguyen

FDA Uses EUAs Broadly In The Fight Against Covid-19

By: Julie Y. Park