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
President Trump took steps to dismantle California’s vehicle emissions standards on June 12, 2025, by signing three Congressional Review Act (“CRA”) resolutions revoking California’s waiver under the Clean Air Act. The waiver...more
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
In the weeks since Holland & Knight previously reported on challenges to California's Clean Air Act (CAA) preemption waivers on April 30, 2025, Congress has taken decisive action. Following the U.S. House of Representatives'...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
Under Clean Air Act (CAA) Section 209(a) (42 U.S.C. § 7543), states are preempted from adopting or enforcing emissions standards for new motor vehicles or new motor vehicle engines. However, because California had adopted its...more
Good morning! This is Akin’s newsletter on climate change policy and regulatory developments, providing information on major climate policy headlines from the past week and forthcoming climate-related events and hearings...more
In a significant development for environmental law and state autonomy, the Supreme Court of the United States (SCOTUS) recently declined to review whether the U.S. Environmental Protection Agency (EPA) has the authority to...more
In November 2019, President-elect Donald Trump’s first administration’s withdrawal of California’s emissions waiver went into effect. ...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
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
California’s ambitious zero-emission, heavy-duty truck regulations face new legal challenges. Our Environment, Land Use & Natural Resources Group outlines the status of California’s Advanced Clean Fleet (ACF) Regulation,...more
March and April have been busy months for vehicle emission regulation in the U.S. On March 20 and March 29 respectively, the U.S. Environmental Protection Agency (U.S. EPA) issued a set of final emission rules setting...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
On March 9, 2022, the US Environmental Protection Agency (EPA) rescinded a rule promulgated by the Trump Administration and revived California’s Clean Air Act waiver, allowing the state to set its own greenhouse gas emissions...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
I noted in yesterday’s post about the NHTSA proposal to withdraw the SAFE I Rule that EPA was expected to follow the NHTSA action by restoring the Clean Air Act Section 209 waiver for California’s Advanced Clean Car program....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
Ninth Circuit Upholds U.S. EPA Waiver to CARB Regarding “Non-Road” Diesel Engine Regulations - On February 10, 2021, the U.S. Court of Appeals for the Ninth Circuit denied a challenge to the U.S. Environmental Protection...more
Multi-state coalition’s lawsuit challenges Trump EPA withdrawal of California Clean Air Act waiver. EPA formally announced its decision to withdraw California’s 2013 Clean Air Act waiver, which allowed the state to set its...more
Yesterday President Trump announced on Twitter that the U.S. was revoking California’s waiver under the Clean Air Act (CAA) which allowed it to impose stricter tailpipe emission standards than the federal ones. California’s...more
WV DEP Waives Clean Water Act Authority Over Atlantic Coast Pipeline - "The West Virginia Department of Environmental Protection waived the state's authority under the federal Clean Water Act to determine if another major...more