Alerts

As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for ventilators, accessories, and other respiratory devices.

With the COVID-19 pandemic, dealers are handling complicated health and business issues. We talked with Aaron Jacoby about the impact of FMLA amendments and how they are designed to provide relief for employees and employers. 

On March 16, 2020, United States Attorney General William Barr issued a memo directing all U.S. Attorneys to prioritize the detection, investigation, and prosecution of COVID-19-related fraud, amid reports of scams, malware, and other fraudulent efforts designed to capitalize on the pandemic. 

Today, Governor Larry Hogan has taken his most aggressive measure yet to protect public safety and prevent COVID-19’s spread. Effective at 8:00 p.m., today, he has ordered everyone who resides in Maryland to remain at home.

Over the past weekend, the FDA issued yet another Final Guidance to relax the rules governing medical devices.

As part of its ongoing effort to address the critical shortage of Personal Protective Equipment (PPE) needed to address the COVID-19 pandemic, FDA has issued an Enforcement Policy to help expand the availability of surgical apparel for healthcare professionals, including gowns and gloves.

The COVID-19 pandemic has led to widespread reports of price gouging on hand sanitizer, protective masks, gloves, and other essential supplies.

Governor Ralph Northam, like his Maryland counterpart, today issued an Order that requires people in Virginia to remain at home. 

In some of our previous Legal Alerts concerning insurance coverage for coronavirus related issues, we have highlighted some of the types of coverage that could apply to a COVID-19 related loss, such as business interruption, contingent business interruption, civil authority, and event cancellation.

As the coronavirus pandemic continues to impact employers’ business operations, employers with unionized workforces are faced with making business decisions while fulfilling their obligation to bargain with their employees’ collective bargaining representatives.   

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

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

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).

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.

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.

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

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.

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.

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 appropriates $150 billion toward COVID-19 relief for fiscal year 2020. The vast majority of this amount will go to the states, although $3 billion is reserved for distribution to the District of Columbia and U.S. territories, and $8 billion will go to Tribal governments.

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

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.

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).