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
Case Studies for Build America, Buy America Infrastructure Projects – Review of recent changes to government procurement and Buy America laws relating to infrastructure projects. Includes case studies covering construction...more
The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more
California continues to push toward its statewide carbon-neutrality goals. On August 25, 2022, the California Air Resources Board (CARB) unanimously approved regulations that require all new 2035 and later passenger...more
Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor. ...In its mission to reward value over volume, the Centers for Medicare & Medicaid Services’ (CMS)...more
On September 1, 2020, the US Department of the Treasury (Treasury) and Internal Revenue Service (IRS) released final regulations on the base erosion and anti-abuse tax (the BEAT) under section 59A. These regulations finalize...more
One of the great innovations of the Part 107 regulations for unmanned aircraft was the ability to obtain a waiver from many of its more restrictive requirements. The Part 107 waiver process allows operators the flexibility to...more
The German government seeks to promote the prospering of the German economy as finding skilled employees from the German labour market becomes more difficult for many employers, especially in the industries of nursing care...more
On June 21, 2016, the Federal Aviation Administration (FAA) released its long awaited amendments to regulations for the operation of small unmanned aircraft systems (“UAS”), defined as aircraft weighing less than 55 pounds....more