Thursday, November 04, 2010 1:27 AM
‘FDA Fails at Monitoring Device Safety’ says Report
Report in BMJ claims agency is bogged by lax approval procedures and poor follow-up.
In what could be another case of bad publicity for the U.S. Food and Drug Administration, a new report in The British Medical Journal has charged the agency of doing a poor job of monitoring medical device safety. The report specfically targets the device office for being lax in both its initial approval and ongoing post-market monitoring of devices. Instructor at the Dartmouth Institute for Health Policy and Clinical Practice and lead author Shannon Brownlee, commented that ‘the ag more...
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