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
The wireless industry has revolutionized the way we connect, from facilitating teleworking, distance learning, and telemedicine to allowing the American public to interact virtually in almost all other aspects of their daily...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
Calls for Significant Changes To Federal Domestic Preference Policy, Waivers, and Buy American Eligibility - President Biden signed an executive order (order or EO) on January 25, 2021, to direct more spending of the...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
Last week was apparently CFC week at the Federal Circuit, with several precedential decisions in government contracts and Tucker Act cases. Below we give our usual week’s statistics and case of the week—our highly subjective...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
In an effort to curb the potential risk associated with reliance upon the Russian Federation for energy, the Department of Defense issued a class deviation that prohibits contractors from using any Russian-sourced energy to...more
The Government Accountability Office (GAO) recently published a report on the federal government implementation of the Buy American Act. The Buy American Act of 1933 is one of several statutes implementing a preference for...more
• Four bills are currently pending in Congress to repeal or limit the reach of the Jones Act, including three that are focused upon relief efforts to assist Puerto Rico after the disastrous effects of Hurricane Maria. •...more
• A disruption of refinery operations and ocean shipping on the U.S. Gulf Coast in the wake of Hurricane Harvey may spur oil industry requests for a waiver of the Jones Act to permit non-U.S. vessels to move crude oil and...more
The Government Accountability Office (GAO) has exhibited little interest in evaluating the basis for agency decisions to waive organizational conflicts of interest (OCI). Where protesters have challenged agency waiver...more
On December 7, 2012, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) issued its first decision determining that government contractors need to challenge any obvious errors, improprieties, or ambiguities...more