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
As we approach the second anniversary of the EU Foreign Subsidies Regulation (FSR), we take stock of the latest statistics and offer practical insights for private equity (PE) sponsors. Drawing on our extensive experience...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
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
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
The U.S. Department of State has announced a major update to the Exchange Visitor Skills List, effective December 9, 2024. This is the first significant revision in 15 years and removes the two-year home-residency requirement...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
Strike 3 Holding, LLC is a prolific filer of federal copyright infringement actions. They have filed thousands of lawsuits across the United States in states like Illinois, Pennsylvania, New Jersey, New York, Florida, Texas...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
As we enter the third year of the pandemic, life with COVID-19 has become the new “normal” for many Americans. While debate can be had about when a pandemic ends or becomes endemic, there is no dispute that more and more...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
The Illinois Biometric Information Privacy Act (BIPA 740 ILCS 14/1 et seq.) requires businesses to notify individuals before collecting their biometric identifiers such as fingerprints (click here to read our previous client...more
On June 8-9, 2021, the World Trade Organization’s (WTO) TRIPS Council will hold their first meeting in the wake of the U.S. Trade Representative (USTR) announcing “the Biden-Harris Administration’s support for waiving...more
On January 14, the Federal Aviation Administration approved the first fully automated commercial drone flights by granting Massachusetts-based American Robotics, Inc. permission to operate drones without hands-on piloting and...more
On July 15, 2020, the IRS issued interim guidance (IG) providing instructions to examiners on how to inform churches of the option to authorize the Service to consider church claims for refund or requests for abatement...more
IRS Notice 2020-51, released last week, provides additional guidance on the waiver in 2020 of required minimum distributions (RMDs) from defined contribution retirement plans and IRAs, and the interaction of this waiver with...more
In the event of a national disaster or emergency under the Stafford Act or the National Emergencies Act and a Public Health Emergency Declaration by government officials, the Department of Health and Human Services (HHS)...more
On June 4, 2020, the IRS released Notice 2020-39, which provides five key relief provisions for qualified opportunity funds (QOFs) and their investors in response to the ongoing COVID-19 pandemic: •Extends the time period...more
In response to the COVID-19 pandemic, on March 17, 2020, the Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) issued a notification of enforcement discretion, announcing that it would not...more
The federal Department of Health and Human Services (HHS) on March 13, 2020, invoked its authority under section 1135 of the Social Security Act (the act) to waive certain requirements that providers normally must meet to...more
Responding to the COVID-19 national public health emergency, on March 13, 2020, the Secretary of the U.S. Department of Health and Human Services (HHS) exercised the authority granted by Section 1135 of the Social Security...more
If 2018 was a year of elevator music at the National Labor Relations Board, 2019 was symphony of sound. The Board’s initiatives were varied, high-profile and in the vast majority of cases, the developments were positives for...more
I’m not a fan of reporting legislation, but this piqued my interest. Sen. Pat Toomey (R-PA), a member of the Senate Finance Committee, is working on a bill that would allow plan participants to withdraw funds from their...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
With cybercrime on the rise, organizations have increasingly found themselves subject to litigation or regulatory investigations related to breaches. Documents and information created before breaches, such as security...more
Protection of industrial control systems is crucial to the security of our country. The National Cybersecurity Center of Excellence (NCCoE) has announced a project for which it is seeking comment: Detecting and Protecting...more