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January 6, 2021, MedTech Insight
Scott Danzis is quoted in MedTech Insight regarding the FDA’s final guidance on its new Safer Technologies Program for Medical Devices (STeP) program, which is intended to provide additional support to developers of medical devices that significantly improve on existing products. Mr. Danzis says that STeP is a "welcome complement" to the FDA's Breakthrough ...
Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses
September 29, 2017, Regulatory Focus
Scott Danzis is quoted in a Regulatory Focus article regarding the allowance of third-party reviews under the FDA Reauthorization Act. “While the revised statute does allow for implantable, life sustaining, or life supporting devices to be eligible for third party review, we expect that FDA will be cautious in adding such devices to that program," Danzis says. ...
Life Sciences Group Of The Year: Covington & Burling
February 10, 2017, Law360
Law360 selected Covington’s Life Sciences practice as a “Practice Group of the Year,” highlighting the firm’s involvement in billion-dollar transactions, success in contentious litigation, and regulatory advice on cutting-edge technology. According to Michael Labson, “What we offer and bring to complicated, complex issues is a mixture of deep subject-matter ...