The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
When it comes to regulating motor vehicle emissions, California has long been different. California was the first state in the nation to enact tailpipe emission standards and as result of its "pioneering" efforts in the...more
On February 18, 2025, the U.S. Department of State superseded and updated its previously issued December 2023 post-COVID guidance on non-immigrant interview waiver applications. Under the revised guidance, Important Update on...more
The U.S. Department of State has announced updated guidance restricting eligibility for nonimmigrant visa interview waivers at U.S. Consulates. Under the revised guidance, nonimmigrant visa applicants may be eligible for an...more
On the day of his inauguration, President Joe Biden issued a historic number of executive orders, several of which focused on overturning actions taken by the Trump Administration’s Environmental Protection Agency (EPA). We...more
Key Points - On July 28, 2023, President Biden signed EO 14104, “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs,” which aims to increase domestic manufacturing and...more
“The provision of health care services via telemedicine has been growing in popularity over the last several years. With the arrival of the COVID-19 pandemic, healthcare providers were able to rely on a variety of temporary...more
On July 15, 2022, the U.S. Department of Labor (DoL) published a 160-page Notice of Proposed Rulemaking (NPRM) to implement Executive Order (EO) 14055, “Nondisplacement of Qualified Workers Under Service Contracts,” seeking...more
In March, we wrote about how we still were awaiting guidance from the White House about how the Made in America Office’s waiver process would work under President Biden’s January 25, 2021 EO 14005, Ensuring the Future is Made...more
New York’s State Disaster Emergency declaration, which had been extended through June 24 through a series of Executive Orders by Gov. Andrew Cuomo, has expired. Among many other things, the Executive Orders had removed...more
“Now, the next part is very important…” As scrutiny of domestic preference requirements increases in the wake of the Biden Administration’s Executive Order on Ensuring the Future Is Made in All of America by All of...more
Since the COVID-19 public health emergency was initiated in Arkansas in March 2020, Governor Asa Hutchinson has repeatedly renewed the emergency order, maintaining the public health emergency for fourteen (14) months. ...more
It has been two months since President Biden issued his Buy American Executive Order on January 25, 2021. But it would seem we still have more questions than answers: What specific actions will agencies take to promote the...more
The United States Government is the world’s biggest single buyer, spending approximately $600 billion a year on purchases. Since 1933, with the passage of the Buy American Act, the federal government has, with varied degrees...more
On January 25, President Biden signed an Executive Order that contemplates increasing the domestic content thresholds and price preferences for domestic goods under the Buy American Act ("BAA," 41 U.S.C. §§ 8301-8305). The...more
Calls for Significant Changes To Federal Domestic Preference Policy, Waivers, and Buy American Eligibility - President Biden signed an executive order (order or EO) on January 25, 2021, to direct more spending of the...more
On January 25, 2021, President Biden signed the Ensuring the Future Is Made in All of America by All of America’s Workers (Made in America) Executive Order, which not only directs that federal government purchases and...more
The Department of Consumer Affairs (DCA) continues to issue and extend waivers under Governor Newsom’s March 30, 2020 Executive Order, which authorized the DCA to temporarily modify licensing and staffing requirements for...more
This 27th edition of Unprecedented, our weekly update on COVID-19-related litigation, sees us start with a discussion of a trend toward class actions, with later discussions on two key areas -- insurance coverage disputes and...more
On September 23rd, Governor Gavin Newsom issued a precedent-setting executive order cementing California’s continued effort to take the lead on clean vehicle policy. Executive Order N-79-20 establishes as a goal that, where...more
On August 4, 2020, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to update its payment policies under the Medicare Physician Fee Schedule (PFS) for calendar year 2021. The proposed rule was...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more
As more workers begin to return to the workplace, it is expected that there will be an increase in the number of lawsuits related to employee contraction of the virus in the workplace. While the general rule in most states is...more
In our prior bulletin, we discussed the likely lack of civil immunity from Justice Center enforcement actions conferred in other contexts by Executive Order 202.10. However, other Executive Orders provided some relief in the...more
Lawmakers and citizens across the country are engaged in disputes over the breadth and duration of shutdown orders intended to slow the spread of the novel coronavirus. Pennsylvania was the first state, however, to have...more