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King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

Hogan Lovells

State Licensing Spotlight – Prescription Medical Device Manufacturers & Distributors: Enforcement and penalties for operating...

Hogan Lovells on

The regulatory environment for prescription medical device manufacturers and distributors has become increasingly stringent as state-based agencies work to ensure public health and safety. Operating without a required license...more

Conyers

Increased Enforcement Actions Regarding Cayman Islands Economic Substance

Conyers on

In 2024, there has been a sharp increase in the number of enforcement actions initiated by the Cayman Islands Tax Information Authority (“TIA”) and fines levied against relevant entities (such as Cayman Islands exempted...more

Farrell Fritz, P.C.

Town Of East Hampton Runs Aground At Truck Beach

Farrell Fritz, P.C. on

Last week, in The Seaview at Amagansett, Ltd. v. Town of East Hampton Justice Paul J. Baisely, Jr. found the Town of East Hampton and several of its officials in civil and criminal contempt of the Appellate Division, Second...more

Freeman Law

The FBAR (Report of Foreign Bank and Financial Accounts): Everything You Need to Know

Freeman Law on

What is the Report of Foreign Bank and Financial Accounts (FBAR)? Congress enacted the statutory basis for the requirement to report foreign bank and financial accounts in 1970 as part of the “Currency and Foreign...more

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