The sequence of legislative enactments underpinning FDCA and CLIA reflects that Congress viewed (1) ensuring medical-device safety ... with FDA’s five stages of phased-in regulation of LDTs ...

The FDA has issued a Complete Response Letter to Telix Pharmaceuticals regarding the NDA for TLX101-CDx for the imaging of gliomas.

A Texas judge has ruled against the US Food and Drug Administration (FDA) in a court case that challenged the agency’s plans to regulate laboratory-developed tests (LDTs) – defined as in vitro ...

[1] The court’s judgment vacates the agency’s controversial final rule of May 6, 2024 (“Final Rule”), regulating LDTs as medical ... (e.g., through sending FDA warning letters to clinical ...

Litigation against the FDA's Final Rule on lab-developed tests (LDTs) is causing uncertainty to rise as the US regulator gears up for a legal clash with the lab industry. Since the FDA revealed ...

The U.S. FDA famously lost a lawsuit over its final rule for regulation of lab-developed tests (LDTs), but Jeff Shapiro of King & Spalding told BioWorld that the implications of this decision go ...

The U.S. Food and Drug Administration (FDA) and Novo Nordisk are warning people not to use counterfeit semaglutide 1.0 mg (Ozempic injection) found in the US drug supply chain. Novo Nordisk ...