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
Terrell v. Kiromic Biopharma, Inc., No. 131, 2024 (Del. Jan. 21, 2025) - In a decision addressing the interpretation of waiver clauses within stock option agreements, the Delaware Supreme Court reversed the Court of...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
Vachon v. The Travelers Home and Marine Insurance Company, Fla. 2d DCA, No. 2d2023-2674, Feb. 14, 2025 - The Second District Court of Appeals considered whether an insurer can raise, as the basis of a motion to dismiss or as...more
Recently, in the case United States v. Miller, the U.S. Supreme Court held that the sovereign immunity waiver provision in the Bankruptcy Code is jurisdictional only and does not waive the federal government’s sovereign...more
On February 11, SEC Acting Chair Lee announced that the Commission no longer would permit settlements in enforcement actions to include, or be contingent on the grant of, waivers of statutory disqualifications that flow from...more
The Center for Biological Diversity, Defenders of Wildlife, and Animal Legal Defense Fund (collectively “CBD”) filed an October 17th Complaint for Declaratory and Injunctive Relief (“Complaint”) challenging the issuance of...more
We finally have an answer to the question of whether parties can contractually waive the right to a “fair market value” hearing under Arizona law – and the answer, according to the Court of Appeals – is “no.” ...more