Arent Fox continues to monitor the FDA activities and scientific reports on COVID-19 and the novel coronavirus.

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.

Timelapse photo of W46th street in NYC at night

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

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 DHS and ICE have issued Guidance Documents, Frequently Asked Questions, and a Reporting Template to guide higher education officials in staying in compliance with the applicable rules.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, estimated to cost more than $2 trillion dollars, contains multiple tax-related provisions intended to offer relief to both businesses and individuals. Here we outline key provisions of which businesses and individuals should be aware.

If history is any guide, the ongoing coronavirus pandemic will provide many opportunities for fraudsters to separate the desperate and vulnerable from their money and personal information.

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.

To address the COVID-19 national emergency, hospitals throughout the country are seeking to bolster their ranks of health care providers.

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.

Governor Cuomo directed the Empire State Development Corporation (ESD) on March 27, 2020 to update New York State’s Guidance for various businesses, including construction, under the Governor’s New York State on “PAUSE” Executive Orders (EO 202.6 and thereafter).

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).

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.

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

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.

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.

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.

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.

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.

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.

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.

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.