Greater FDA Oversight of Laboratory-Developed Tests: A Needed Change? cancertherapyadvisor.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from cancertherapyadvisor.com Daily Mail and Mail on Sunday newspapers.
The agency issued a rule that brings new scrutiny to a range of critical lab-developed tests, including certain cancer and prenatal screenings. ProPublica previously reported how lab-test accuracy and marketing had skirted federal oversight.
Lab-developed tests like prenatal screenings have become increasingly popular, all while escaping the bulk of federal scrutiny over marketing and accuracy. Now, the FDA is beginning the process of imposing regulations on these kinds of tests.
Lab-developed tests like prenatal screenings have become increasingly popular, all while escaping the bulk of federal scrutiny over marketing and accuracy. Now, the FDA is beginning to impose regulations on these tests.
by Anna Clark ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. After decades of intense debate and stalled legislation, the Food and Drug Administration has taken a critical step in overseeing a vast category of lab tests that reach patients without any federal agency checking to ensure they work the way their makers claim. Among the tests that are not.