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
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
For over a decade, many California employers have issued written meal period waivers that permit employees to voluntarily agree to prospectively waive 30-minute meal periods throughout their employment and under certain...more
The California Labor Code generally requires that employers provide meal periods to non-exempt employees working more than five hours. However, the Labor Code provides that meal periods can be waived by agreement of the...more
Employers in California often offer employees the ability to sign “meal period waivers,” usually at onboarding. These written waivers reflect the employee’s agreement, on a going-forward basis, to waive their first meal...more
In 2023, the Federal Motor Carrier Safety Administration (“FMCSA”) under the Biden administration started accepting public comments about the many petitions for waiver that key stakeholders, including the California Attorney...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
Hospital at Home (“HaH”) programs received renewed interest during the COVID-19 pandemic as a way to relieve hospital capacity issues and allow patients to receive effective care outside of the traditional hospital setting....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
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 Attorney General Rob Bonta (AG) and Assembly Speaker pro Tempore Jim Wood recently introduced legislation (AB-3129) that would authorize the AG to review private equity group and hedge fund health care...more
On February 16, 2024, Assemblymember Jim Wood introduced Assembly Bill (AB) 3129, which targets healthcare consolidation involving private equity groups and hedge funds. The bill, if enacted, would require private equity...more
The 340B Drug Program requires pharmaceutical manufacturers participating in the Medicaid program to provide covered outpatient drugs at significantly reduced prices to certain health care organizations and programs, referred...more
In the spirit of the season, we are using our annual "12 Days of California Labor and Employment" blog series to address new California laws and their impact on California employers. On the third day of the holidays, my labor...more
Seyfarth Synopsis: In August, the Federal Motor Carrier Safety Administration (“FMCSA”) announced that it would start accepting petitions for waivers from the recent decisions preempting California and Washington’s meal and...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
California’s Density Bonus Law provides housing developers with tools to encourage the development of much needed affordable and senior housing. The California Legislature has continued to refine the Density Bonus Law over...more
California Attorney General Rob Bonta has never minced words in expressing his position that consumers should be protected from guaranteed asset protection (GAP) waivers. This trend continued with his sponsorship of AB 2311,...more
In a much-needed win for employers, the U.S. Supreme Court has ruled that waivers of employees’ individual claims under California’s Private Attorneys General Act of 2004 (PAGA) are enforceable. The court’s decision in Viking...more
The U.S. Supreme Court has given businesses with California employees the option (at least for now) to avoid employee-initiated court proceedings under California’s Private Attorneys General Act (PAGA). On June 15, 2022, the...more
California’s Private Attorney’s General Act (“PAGA”) has created an extremely friendly litigation environment for employees in California. While the 2021 Ninth Circuit decision in Bernstein v. Virgin Am., Inc., 3 F.4th 1127...more
More than 13 million people were enrolled in Medi-Cal in California in September 2021, making it the largest Medicaid program in the nation. In December 2021, the Centers for Medicare & Medicaid Services (CMS) approved the...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