Regulatory & Reimbursement
FDA Hit Hard by Layoffs, LDT Regulation is Dead, Global “Reliance” Plan Floated
In this week’s Pathways Picks: HHS moved ahead with cutting about 18% of FDA’s workforce; a federal judge resoundingly rejected FDA’s authority to regulate laboratory-developed tests; guidance on “sex-specific” device study data resurfaces; IMDRF issues draft playbook on global regulatory reliance; Australia enacts its UDI requirements; South Africa institutes quality management mandates; and more.
