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The China Food and Drug Administration has ordered 18 devicemakers to stop publishing advertisements that make false claims about the effectiveness of their products — a move some say shows a new willingness to crack down on illegal ads. Read More
The FDA has rejected a call for a total ban on transvaginal mesh products, saying complete market withdrawal is not an appropriate way to deal with serious safety concerns linked to the devices. Read More
The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, used with its Renasys line of negative pressure wound treatment devices. Read More
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
Emailing recall notices to clients may seem efficient, but it could cause a host of concerns around confidentiality and effectiveness, a CDRH official warns. Read More
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