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
The Congressional Review Act (“CRA”), enacted in 1996, allows Congress to disapprove federal regulations promulgated by government agencies within 60 legislative working days after the rule is submitted to Congress. In order...more
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 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
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
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