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
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...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
On August 18, 2023, the U.S. Department of Commerce (Commerce) issued final determinations in its circumvention inquiries regarding the import of certain solar cells and modules from Cambodia, Malaysia, Thailand and Vietnam...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
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...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
On February 1, 2023, the U.S. International Trade Commission (the “ITC”) initiated an investigation into the impact of intellectual property (“IP”) rights on the production, supply, and availability of diagnostics and...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
The landmark Bipartisan Infrastructure Law (“BIL”) is a once-in-a-generation initiative to address aging U.S. infrastructure needs and equalize greater access to public resources. While the Administration continues to move...more
Passing the historic $1 trillion Infrastructure Investment and Jobs Act (IIJA) in November 2021, which allocates more than $550 billion in new infrastructure spending, was an early priority of the Biden administration. The...more
While the United States continues to assess the full scope of the devastating aftermath of Hurricane Ida on the U.S. Gulf Coast, national media have already reported shortages of oil and fuel supplies, as well as food and...more
In this new episode of OnAir: Health Care, Akin Gump health care senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Akin Gump public law and policy partner Clete Willems and Centrient...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
It has been two months since President Biden issued his Buy American Executive Order on January 25, 2021. But it would seem we still have more questions than answers: What specific actions will agencies take to promote the...more
The United States Government is the world’s biggest single buyer, spending approximately $600 billion a year on purchases. Since 1933, with the passage of the Buy American Act, the federal government has, with varied degrees...more
Section 889(a)(1)(B) of the NDAA for Fiscal Year 2019 is now in effect. This section of the NDAA prohibits government agencies and government contractors they work with from using certain covered telecommunications equipment...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
GE Healthcare is provided 18 months to bring affected medical devices into compliance. Supply chain disruptions can lead to noncompliance with FCC rules....more
President Donald Trump signed the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (NDAA) (Pub. L. No. 115-232) into law on August 13, 2018. Section 889 of the NDAA applies to schools, including hospital...more
After first invoking the Defense Production Act (DPA) on March 18, 2020, President Donald Trump has taken several actions to formally deploy the authorities we discussed in our March 20, 2020, client alert, “President Trump...more
Amid the economic shocks caused by the Coronavirus (COVID-19) crisis, many industries are facing reduced demand for their products and services. Other industries—notably healthcare and food—are adjusting rapidly to expanding...more
On March 25, 2020, the Senate voted 96-0 to approve the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The House is expected to vote on this bill on Friday, March 27....more