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
Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81. The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more
On May 3, the Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) issued an Advanced Notice of Proposed Rulemaking (ANPRM) that would prohibit executive...more
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
Almost a year to the day after the Build America Buy America Act (BABA) became law, the federal Office of Management and Budget (OMB) has published its “Final Guidance for Grants and Agreements” intended to implement BABA’s...more
The White House issued final guidance this week governing the procurement preferences required by the Build America, Buy America Act, or BABA, for infrastructure projects. In addition to providing definitions for key terms...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
“Now, the next part is very important…” As scrutiny of domestic preference requirements increases in the wake of the Biden Administration’s Executive Order on Ensuring the Future Is Made in All of America by All of...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