FDA’s Breakthrough Designation Now Includes Health Equity Provision
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
Keeps You Up-to-Date on New Diagnostic Tests, Testing Trends and Opportunities, and Emerging Test Technologies
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
From - Diagnostic Testing & Emerging Technologies
In a continued reversal of its 2013 crackdown on direct-to-consumer (DTC) genetic tests, the U.S. Food and Drug Administration (FDA) unveiled…
From - Diagnostic Testing & Emerging Technologies
Undeniably, much of the emerging test focus is on cancer and infectious diseases. DTET wants to showcase other novel tests entering the marketplace. What follows is…
From - Diagnostic Testing & Emerging Technologies
The CMS Final Fee Schedule will hurt patient access to clinical laboratories, says the lab accreditation bureau COLA…