On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S....more
2/12/2020
/ Administrative Proceedings ,
Appeals ,
Bid Protests ,
Bid Solicitation ,
Country of Origin ,
Court of International Trade ,
Department of Veterans Affairs ,
Federal Acquisition Regulations (FAR) ,
Federal Procurement Systems ,
Generic Drugs ,
India ,
Made in the USA ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Statutory Interpretation ,
Supply Contracts ,
Trade Agreements Act
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