FDA Uses EUAs Broadly In The Fight Against Covid-19
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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.
- - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, PharmaOn 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... ›
HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation
By: Erin M. Bosman and Julie Y. ParkOn 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... ›
Morrison & Foerster Expands Corporate Capabilities Adding New Corporate Co-Chair Mitchell Presser
By: Mitchell S. PresserMorrison & 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... ›
Should Employers Require Employees to Wear Facemasks?
By: Miriam H. Wugmeister and Eric GebertAs 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... ›
Germany, UK, USA: Are Patent Exceptions the Cure to COVID-19?
By: Wolfgang Schönig, Alistair Maughan and Robert GrohmannAs 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... ›
- - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Biotech, Healthcare, Pharma
CARES Act of 2020: Guide for Drug and Device CompaniesThe 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... ›
HHS Suspends Penalties to Encourage Sharing of COVID-19 Data by Business AssociatesOn 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... ›
- - 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. ParkAs 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... ›
Federal Antitrust Agencies Encourage Appropriate Competitor Collaboration to Address the COVID-19 Crisis
By: David D. CrossThe 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... ›
FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked
By: Erin M. Bosman and Julie Y. ParkLast 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... ›