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Australia’s Therapeutic Goods Administration logged a total of 3,309 adverse event reports in 2013, the overwhelming majority from manufacturers, according to a new report. Read More
The U.S., Canada, Australia and Brazil were supposed to begin shared audits this month under the International Medical Device Regulators Forum’s medical device single audit program. Read More
Coronary devicemaker HeartWare International has received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility. Read More