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
In June 2024, the Biden Administration announced several immigration actions using the authority of the executive branch. Within a political landscape of stalemate on virtually all things immigration, it has not been unusual...more
It came as something of a shock in May, 2021 when the Biden administration voiced support for waiver of intellectual property protection mandated under the TRIPS agreement for COVID-19 vaccines (see "Biden Administration...more
Seyfarth Synopsis: The Federal Motor Carrier Safety Administration determined only a few years ago that federal law preempts California’s and Washington’s meal and rest period rules. Regardless of what would happen in the...more
President Joe Biden signed into law the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 (2023 NDAA or Defense Bill) on Dec. 23, 2022. The Defense Bill, which passed the U.S. House of Representatives on...more
Key Points - On December 6, days before a deadline for WTO members to decide whether to expand the TRIPS waiver for COVID-19 vaccines to cover COVID-19 diagnostics and therapeutics as well, the Office of the USTR...more
It is often observed (or asserted) that a fair compromise in a dispute has likely been reached when both sides are not particularly happy about it. This is not always the case, of course, and is more likely not to be the...more
On November 15, the Senate approved a resolution to end the national emergency concerning COVID-19 declared by the president on March 13, 2020. The resolution was approved by a bipartisan vote of 62–36, with 13 Democrats...more
California continues to push toward its statewide carbon-neutrality goals. On August 25, 2022, the California Air Resources Board (CARB) unanimously approved regulations that require all new 2035 and later passenger...more
The Biden administration gave its stamp of approval last week to Colorado’s novel waiver under Section 1332 of the Affordable Care Act (ACA) to require premium reductions in a public option program, a first-of-its-kind plan...more
Passing the historic $1 trillion Infrastructure Investment and Jobs Act (IIJA) in November 2021, which allocates more than $550 billion in new infrastructure spending, was an early priority of the Biden administration. The...more
The Infrastructure Investment and Jobs Act (IIJA), which included the Build America, Buy America Act (the Act), was signed into law on Nov. 15, 2021, and created a deadline of May 14, 2022, for federal agencies to ensure...more
In a move that was telegraphed at the outset of the Biden-Harris administration, the US Environmental Protection Agency announced March 9 that it is reversing a Trump-era decision to revoke California’s authority to set...more
On January 22, 2022, Georgia and the Georgia Department of Community Health filed suit against the Centers for Medicare & Medicaid Services (CMS) seeking to prevent the rescission of the central aspects of Georgia’s 1115...more
On October 29, 2021, Iowa Governor Kim Reynolds signed into law legislation affecting the interplay between Iowa employers, employees, and COVID-19 vaccine requirements. Iowa’s new law, HF 902, sets up questions regarding...more
While the United States continues to assess the full scope of the devastating aftermath of Hurricane Ida on the U.S. Gulf Coast, national media have already reported shortages of oil and fuel supplies, as well as food and...more
In this new episode of OnAir: Health Care, Akin Gump health care senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Akin Gump public law and policy partner Clete Willems and Centrient...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
On May 26, SBA Administrator Isabella Casillas Guzman began a series of hearings on the Hill that will continue through May 28. On May 26, she testified before the House Committee on Small Business in a hearing titled “An...more
Last week, the National Highway Traffic Safety Administration proposed to withdraw Part I of the Trump Administration’s SAFE Rule, in which EPA had concluded that California’s regulation of motor vehicle GHG emissions was...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
The past few weeks have ushered in signs of what’s likely to come from the SEC’s Division of Enforcement under the Biden Administration, including a greater number of investigations and a tougher path to “bad boy” waivers for...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