FDA issues final rule on clinical trials diversity

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.

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.

Federal judge upholds FDA authority over lab-developed tests

5. oktober 2025 Rapportert av AI

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 proposes rule to protect Medicaid enrollees from improper terminations

2. oktober 2025 Rapportert av AI

The Centers for Medicare & Medicaid Services has issued a proposed rule to strengthen safeguards for Medicaid eligibility determinations. This move addresses widespread coverage losses during the post-pandemic unwinding process. The rule aims to ensure states comply with federal requirements for notices and appeals.