Federal judge upholds FDA authority over lab-developed tests

A U.S. federal judge has ruled that the Food and Drug Administration (FDA) possesses the authority to regulate lab-developed tests (LDTs) as medical devices. This decision comes amid ongoing debates over the oversight of in-house diagnostic tools used by clinical laboratories.

FDA issues final rule on clinical trials diversity

September 30, 2025 Reported by AI

The U.S. Food and Drug Administration has finalized a rule requiring drug sponsors to submit diversity action plans for clinical trials. This aims to ensure better representation of underrepresented groups in medical research. The rule takes effect in 2025.

Senate confirms Robert Califf as FDA commissioner

The U.S. Senate has confirmed Robert Califf to lead the Food and Drug Administration amid ongoing public health challenges. Califf, a cardiologist with prior FDA experience, was approved in a bipartisan vote. This move aims to stabilize the agency during debates over drug approvals and regulations.

House passes bill to boost hospital price transparency

October 01, 2025 Reported by AI

The U.S. House of Representatives narrowly passed legislation aimed at increasing transparency in hospital pricing on September 12, 2024. The measure, sponsored by Republicans, requires hospitals to disclose standard charges for services in advance. The bill now moves to the Senate amid partisan divides.