Announcements

Welcome to Mofo Life Sciences

MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

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 Ph.D.
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 20, 2020 - Corporate + Venture Capital, Agtech, Announcements
Morrison & Foerster Expands Corporate Capabilities Adding New Corporate Co-Chair Mitchell Presser
By: Mitchell S. Presser
Morrison & Foerster is pleased to announce the continued expansion of its New York office and global Corporate Department capabilities with the arrival of corporate partner Mitchell Presser. He joins the firm as a partner in its Mergers + Acquisitions and Private Equity Investments + Buyouts practices and
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April 17, 2020 - United States, COVID-19, Employment
Should Employers Require Employees to Wear Facemasks?
By: Miriam H. Wugmeister, Lloyd Aubry and Eric Gebert
As employers begin considering return to work strategies, many are wondering whether they should permit or require individuals to wear facemasks at work. It may be surprising to many companies, but the Occupational Safety and Health Administration (“OSHA”) has published detailed standards and guidance
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April 16, 2020 - United States, COVID-19, United Kingdom, European Union, Healthcare, Intellectual Property
Germany, UK, USA: Are Patent Exceptions the Cure to COVID-19?
By: Wolfgang Schönig, Alistair Maughan and Robert Grohmann
As the COVID-19 pandemic continues to spread globally, the life sciences industry is at the forefront of addressing the urgent need for pharmaceuticals, diagnostics, ventilators, and personal protective equipment capable of helping to contain the surge. While the laws of many countries provide for
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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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April 03, 2020 - United States, COVID-19, Healthcare, Privacy + Data Security
HHS Suspends Penalties to Encourage Sharing of COVID-19 Data by Business Associates
On April 2, 2020, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced that, effective immediately, it will be halting enforcement of certain HIPAA provisions in order to enable state and federal public health authorities and emergency operations
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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 26, 2020 - United States, COVID-19, Antitrust
Federal Antitrust Agencies Encourage Appropriate Competitor Collaboration to Address the COVID-19 Crisis
The U.S. antitrust agencies – the Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission (FTC) – have recognized a need for “unprecedented cooperation between federal, state, and local governments and among private businesses to protect Americans’ health and safety” during the
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Welcome to Mofo Life Sciences

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

By: Jean Nguyen Ph.D.

FDA Uses EUAs Broadly In The Fight Against Covid-19

By: Julie Y. Park

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

By: Erin M. Bosman and Julie Y. Park

Morrison & Foerster Expands Corporate Capabilities Adding New Corporate Co-Chair Mitchell Presser

By: Mitchell S. Presser

Should Employers Require Employees to Wear Facemasks?

By: Miriam H. Wugmeister, Lloyd Aubry and Eric Gebert

Germany, UK, USA: Are Patent Exceptions the Cure to COVID-19?

By: Wolfgang Schönig, Alistair Maughan and Robert Grohmann

CARES Act of 2020: Guide for Drug and Device Companies

HHS Suspends Penalties to Encourage Sharing of COVID-19 Data by Business Associates

FDA Inspires Modifications and Quick Authorizations for Ventilators

By: Erin M. Bosman and Julie Y. Park

Federal Antitrust Agencies Encourage Appropriate Competitor Collaboration to Address the COVID-19 Crisis