Gottlieb’s Departure Should Not Siderail Reforms to 510(k) Pathway

The unexpected resignation of Dr. Scott Gottlieb from the Food and Drug Administration last week gave the life sciences industry pause. Gottlieb has been an agile leader, who proved himself to be ready and willing to help the agency evolve as the health care sector becomes more technology-centric. It is reported that he issues more than 200 guidances a year, many aimed at easing the way for new technologies including digital therapeutics, gene therapies and wearable medical devices. His two-year … Continued

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