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.

CMS finalizes rule to streamline Medicare prior authorizations

The Centers for Medicare & Medicaid Services (CMS) has finalized a rule to reduce administrative burdens from prior authorization requirements in Medicare Advantage plans. The policy aims to speed up approvals and improve patient access to care. It will affect millions of enrollees starting in 2026.

FDA issues final rule on clinical trials diversity

September 30, 2025 Ti AI ṣe iroyin

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

October 02, 2025 Ti AI ṣe iroyin

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.