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Preload of Generic Software Precludes Finding of Substantial Transformation in U.S. When Replaced with Proprietary Software That Enhanced Functionality

Client Alert | less than 1 min read | 05.31.16

Customs and Border Protection has released its final determination concerning different versions of certain network transceivers and high speed cabling devices that require software to be functional. CBP concluded that “blank” network transceivers imported into the U.S. where proprietary software was first downloaded were substantially transformed in the U.S., whereas network transceivers already programmed with generic software when imported were not substantially transformed by subsequent replacement of the generic software with proprietary software that enhanced and broadened functionality allowing interoperability with different OEM systems.

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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.”...