COVID-19 Alert: FDA updates antibody test policy

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 …›

Patent Offices Extend Certain Deadlines, but Proceed With Caution

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 …›

FDA Uses EUAs Broadly In The Fight Against Covid-19

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 …›

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

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 liability …›

April 17, 2020 - COVID-19, Employment, United States

Should Employers Require Employees to Wear Facemasks?

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 …›

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

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 certain …›

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. …›