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
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
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
A group of 16 Republican AGs, led by Ohio AG Dave Yost, sent a comment letter to the U.S. Environmental Protection Agency (“EPA”) urging it to not reinstate California’s waiver under the Clean Air Act, which the letter argues...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
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