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Software Application Insufficient to Substantially Transform Existing Hardware Components Into a Visitor Management System

Client Alert | 1 min read | 05.19.17

In a Final Determination published in the Federal Register today, Customs & Border Protection held that application software installed on existing computers and on an ID scanner manufactured in China did not substantially transform the individual elements (IS scanner, labels, printer and barcode scanner) of the Visitor Management System. The scanners and printers functioned as such when imported, and the software, while defining a specific use, did not change the basic function of the hardware. Although the FAR contemplates that an “end product” offered under a TAA-covered contract should have a single country of origin, the CBP found each element of the VMS retained its individual country of origin, two of which were from China, a non-designated country.

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Client Alert | 2 min read | 09.18.25

FDA Announces Intention to Initiate an Aggressive Enforcement Campaign Against Misleading Pharmaceutical Advertising

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (HHS) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising. This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”...