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Sunlamp manufacturers would be required to take additional measures to improve the overall safety of tanning beds under new rules proposed by the FDA. Read More
A Senate report that followed an investigation by Sen. Patty Murray’s (D-Wash.) office has found that the FDA’s regulatory system for monitoring the safety of devices failed to quickly identify and resolve the spread of antibiotic-resistant infections linked to duodenoscopes. Read More
The road to grabbing the title of FDA commissioner keeps getting tougher for Robert Califf, with senators from both sides of the aisle putting hurdles in front of his path. Read More
With the FDA expected to issue final guidelines on laboratory-developed tests in the coming months, devicemakers should take steps now to ensure their quality systems are in place, an industry expert says. Read More