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
A new interim rule aimed at safeguarding the federal supply chain prohibits contractors from delivering or using covered articles and sources subject to exclusion or removal orders issued under the Federal Acquisition Supply...more
We recently wrote about “Phase 2” of the federal contract mandate, effective August 13, 2020, that prohibits federal prime contractors from using equipment, systems, or services provided by certain Chinese entities “as a...more
On July 14, 2020, the Federal Acquisition Regulation (“FAR”) Council published a long-awaited interim rule (the “Interim Rule”) implementing the second prong of Section 889 of the 2019 National Defense Authorization Act...more
Continuing threats to the supply chain pose increasing risks to our national security. The new interim Federal Acquisition Regulation (FAR) rule published on August 13, 2019, seeks to address certain of these threats by...more