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
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 what is being heralded a major milestone for personalized medicine, in late May the U.S. Food and Drug Administration (FDA) approved the first…
From - Diagnostic Testing & Emerging Technologies
Effective mid-February the U.S. Food and Drug Administration (FDA) is reclassifying antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used…