Under the title " FDA official urges smart regulation" a short article in the Philadelphia Inquirer online edition uses smart regulation to sum up a necessary new paradigm for Health law. "Caught between wary patients who want safe artificial hips and demanding medical-device manufacturers who want their potentially lucrative gizmos approved yesterday, the top device official at the U.S. Food and Drug Administration told skeptical industry executives gathered Monday at the Convention Center that he was trying to institute a paradigm shift to help all parties.
'It's not safety or innovation, Dr. Jeffrey Shuren said. It's safety and innovation.
'We needed to move away from this construct that safety and effectiveness and facilitating innovation are incompatible," Shuren, director of the FDA's Center for Devices and Radiological Health, said at the Biotech 2011 conference, "They are both sides of our mission."
'It's not safety or innovation, Dr. Jeffrey Shuren said. It's safety and innovation.
'We needed to move away from this construct that safety and effectiveness and facilitating innovation are incompatible," Shuren, director of the FDA's Center for Devices and Radiological Health, said at the Biotech 2011 conference, "They are both sides of our mission."
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