Alerts

Recent state and local executive orders limit or suspend many operations of California dealers and repair facilities. This alert summarizes the effects and penalties of recent orders, which are changing daily. 

As we reported earlier this week, in an effort to increase the domestic supply of hand sanitizer, the US Food and Drug Administration (FDA) recently announced policies that temporarily relax certain requirements for the production of alcohol-based hand sanitizer.

The SEC extended its previously granted public company regulatory relief and issued staff guidance yesterday regarding disclosure obligations in light of the continued complications associated with the COVID-19 pandemic.

On March 24 and 25, the U.S. Department of Labor released guidance on the implementation of the Families First Coronavirus Response Act (FFCRA), which we wrote about here when it passed last week.

FDA has issued a new Enforcement Policy that allows manufacturers of certain FDA-cleared non-invasive devices to expand their use for healthcare professionals to monitor patients remotely during the COVID-19 pandemic.

Since last week when we wrote about the “shelter in place” and “stay at home” orders issued in California, New York, and Illinois, many more states have issued similar orders. The general discussion from our prior alert still applies, but below is an up-to-date list of the states that have adopted the stay-at-home approach to fighting the spread of COVID-19.

Due to “shelter-in-place” or “stay at home” orders that are in place in many jurisdictions throughout the country, government offices are generally closed to the public and public gatherings are limited.

In response to an executive order by California Governor Gavin Newsom, the California Department of Public Health has issued an All Facilities Letter waiving hospital regulatory requirements and suspending regulatory enforcement until June 30, 2020, with certain exceptions.

FDA has just issued what it calls “FAQs on Diagnostic Testing for SARS-CoV-2” that provides information on which tests and which testing laboratories have received Emergency Use Authorization for the testing for the COVID-19 virus.

After midnight on the East Coast on Wednesday, March 25, negotiators from the U.S. Congress and Trump Administration finally agreed to the framework of a historic $2 trillion bill. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) constitutes a new Marshall Plan for our nation.

On March 20, 2020, Governor Cuomo signed the “New York State on PAUSE” Executive Order (“PAUSE Order”) to ensure safety for residents across New York State. Effective 8PM Sunday, March 22, 2020, all statewide non-essential businesses must close all in-person operations.

In response to the COVID-19 outbreak, California has taken the extraordinary action of limiting the regulatory enforcement of most licensed health facility requirements.

FDA has just published a new Guidance that will allow for the suspension of reporting of certain adverse event reports while the COVID-19 pandemic continues.

On March 19, 2020, Gavin Newsom, the Governor of California, issued Executive Order N-3-20, which put in place mandatory stay-at-home restrictions as part of an effort to help contain the novel coronavirus, for an indefinite period of time.

As more and more states order businesses to close their physical locations because of the novel coronavirus pandemic, employers are being encouraged by the federal and state governments to work remotely and not have their employees report to worksites unless they fit into the definition of essential

On Monday, March 23, Governor Inslee signed the “Stay Home, Stay Healthy” Executive Order, effective midnight, March 25. 

The typical path for the Antitrust Division of the US Department of Justice when it determines that a contemplated merger is anticompetitive is to sue in federal court to block the merger.

Arent Fox continues to monitor the latest scientific reports on COVID-19 and the novel coronavirus for issues that may be of general concern to our clients.  

On March 18, 2020, New York Governor Andrew Cuomo signed into law Senate 8091 providing for paid sick leave, family leave, and certain disability leave for employees affected by mandatory or precautionary orders to quarantine or isolate due to the novel coronavirus (COVID-19) pandemic. 

Yesterday, District of Columbia Mayor Muriel Bowser issued an order aimed at significantly slowing the community transmission of COVID-19. 

Current thinking from public health experts is that COVID-19 will affect the American economy for several months.

Maryland Governor Larry Hogan issued an Executive Order on Monday that closed all “non-essential businesses” across the State starting at 5 p.m. on March 23, 2020.

FDA has issued a new Guidance to address certain challenges to clinical trials during the COVID-19 pandemic. This Guidance takes effect immediately and applies to clinical trials of drugs, biologics, and medical devices.

On Wednesday, March 25, 2020, the U.S. Trade Representative (USTR) is scheduled to publish a Federal Register notice requesting comments on the removal of Section 301 tariffs from Chinese medical-care products—including those that have been previously denied an exclusion—needed to respond to the COV

Employers are facing many employment decisions regarding their workforce amid the COVID-19 crisis. H-1B employees have rules particular to them which employers should bear in mind. This e-alert highlights the issues to consider.