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Two House members are calling on HHS Secretary Sylvia Burwell to provide more details of how the department is responding to the Zika outbreak, saying the current status of diagnostic testing for the virus is alarming. Read More
European officials are roughly 90 percent of the way toward reaching an agreement on new regulations for medical devices and in vitro diagnostics, but there are still points of contention, according to one expert. Read More
While Sept. 24 might seem far off, the FDA is urging labelers not to be complacent in meeting that target date for submitting necessary information into the Global Unique Device Identification Database. Read More