FDA Signals Flexibility with COVID-19 Tests

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 to …›

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 …›

May 4, 2020 - CFIUS, United States

CFIUS Filing Fees Become Reality

The U.S. Department of the Treasury announced that on Friday, May 1, 2020, the first-ever filing fees will become effective for joint voluntary notices submitted to the Committee on Foreign Investment in the United States (CFIUS). Notices submitted to CFIUS on or after May …›

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

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 …›

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 …›

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 …›