Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration (FDA) announced that it published a list of 223 drug and...more
On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more
8/10/2020
/ Buy American Act ,
Counterfeit Goods Regulation ,
Countermeasures ,
Department of Defense (DOD) ,
Environmental Protection Agency (EPA) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Infrastructure ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Supply Chain ,
Trump Administration ,
USTR
With reports of widespread shortages of personal protective equipment (PPE) and ventilators and the COVID-19 pandemic continuing to expand nationwide, the Trump Administration has turned to the Defense Production Act (DPA) –...more
4/9/2020
/ Coronavirus/COVID-19 ,
Defense Production Act ,
Exports ,
Federal Contractors ,
FEMA ,
Imports ,
Manufacturers ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Supply Chain
On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade...more
8/14/2019
/ Chain of Distribution ,
China ,
Defense Sector ,
Department of Justice (DOJ) ,
Department of Veterans Affairs ,
Enforcement Actions ,
Failure to Comply ,
False Claims Act (FCA) ,
Federal Acquisition Regulations (FAR) ,
Malaysia ,
Medical Devices ,
Regulatory Requirements ,
Regulatory Violations ,
Supply Chain ,
Trade Agreements Act ,
Unlawful Distribution