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 Eighth Circuit partially reversed a district court ruling denying OptumRx, Inc. (“OptumRx”)’s motion to compel arbitration of Lackie Drug Store, Inc. (“Lackie”)’s putative class action, concluding OptumRx waived...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
Under Fed. R. Evid 502(d), a federal court can assure that an inadvertent disclosure of privileged documents in the case before it will not allow litigants in subsequent cases to argue that such disclosure triggered a...more
The U.S. Court of Appeals for the D.C. Circuit on May 16, 2025, clarified the conditions under which a state waives its Clean Water Act (CWA) Section 401 water quality certification (WQC) authority. In Village of Morrisville...more
The continuing saga of the impact of the U.S. Supreme Court’s Stern v. Marshall decision took a major turn Tuesday when the Court issued its ruling in the Wellness International Network, Limited v. Sharif case. Before...more
On May 26, 2015, the U.S. Supreme Court issued its ruling in Wellness International Network, Ltd., et al. v. Sharif. The Wellness decision clarifies one of the most significant open issues created four years ago by the...more
There were nearly a million bankruptcy cases filed by individuals and businesses in 2014. It is safe to say that only the tiniest fraction of such debtors have any familiarity with the Supreme Court’s decision in Stern v....more