Federal judge upholds FDA authority over lab-developed tests

5. Oktober 2025 Von KI berichtet

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

30. September 2025 Von KI berichtet

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.

HHS Releases MAHA Strategy Report

The Department of Health and Human Services published its highly anticipated MAHA Strategy Report on September 12, 2025. The report outlines strategies for health advocacy and policy improvements.

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.