Alerts

With consumers attempting to navigate quarantine and “shelter-in-place” orders, businesses that sell basic necessities are facing overwhelming demand.

Headlines that Matter for Companies and Executives in Regulated Industries

This updates our prior Alert regarding the importation and distribution of face masks and respirators to be used to meet the significant US health care challenges posed by the COVID-19 pandemic.

Under the CARES Act, a $500 billion pool of money was created to make loans, loan guarantees, and other investments for distressed businesses that do not qualify for the small business relief, including airlines, large nonprofit companies, states, and municipalities.

Teva Pharmaceuticals filed suit against the United States Food and Drug Administration (FDA) alleging that its glatiramer (Copaxone) falls under the revised definition of a “biological product” and should be transitioned to the system established by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

On March 24th, the Department of Labor’s Wage and Hour Division issued its first round of guidance regarding the Families First Coronavirus Response Act.

In recognition of the impact the COVID-19 outbreak is having on every facet of life, the U.S. Environmental Protection Agency (EPA) issued a temporary enforcement discretion policy to excuse certain civil violations occurring during and due to the COVID-19 pandemic.

After initially accepting requests from importers in light of the novel coronavirus (COVID–19) pandemic to defer payment of duties—a means of relief that the Trump Administration had reportedly been considering—US Customs and Border Protection (CBP) has issued guidance withdrawing this option.

Consumers are stuck at home. How does business continue? We talked with Aaron Jacoby and Russ McRory about the impact of state and local “Stay at Home” orders in California and New York and how dealers and manufacturers can navigate the COVID-19 pandemic.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act provides $2 trillion in stimulus in response to the COVID-19 pandemic.

Arent Fox is counseling clients on the business loan programs included in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

Earlier this week, the IRS released updates on the status of its operations as the COVID-19 outbreak continues and also on the IRS’s new People First Initiative. In addition, Illinois extended its tax filing and payment deadline (but not the deadline to make estimated tax payments) to match the IRS July 15 deadline.

As cases of COVID-19 continue to increase across the country, uncertainty in the construction industry about projects, including potential project risks, proliferates.

The soon to be passed Coronavirus Aid, Relief, and Economic Security Act includes these key details surrounding the Health Care Industry, Not-for-Profits, and debt restructurings. 

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.

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.

Like some other states, California has its own state version of the federal Worker Adjustment and Retraining Notification (WARN) Act. 

The Centers for Medicare and Medicaid Services (CMS) issued a memorandum to State Survey Agency Directors that provides further guidance regarding survey priorities for health care facilities, providers, and clinical laboratories due to COVID-19 and other respiratory illnesses.

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.

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.

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.

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.