Federal judge upholds FDA authority over lab-developed tests

5 Mwezi wa kumi, 2025 Imeripotiwa na 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.

House passes bill to boost hospital price transparency

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.

CMS proposes rule to protect Medicaid enrollees from improper terminations

2 Mwezi wa kumi, 2025 Imeripotiwa na 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.

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.