The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation

Oncology, Regulation, Testing, LDTs, FDA, CLIA, CMS

The regulatory landscape for precision oncology in the United States is complex, involving multiple governmental agencies with varying jurisdictions. Since 2014, several regulatory proposals have been introduced following the FDA's draft guidance on laboratory-developed tests. There are ongoing …

May 22^nd • 8 mins read