Although 2018 ended with a government shutdown, for most of the year, new proposals and programs flowed out of Scott Gottlieb's US FDA at a mile-a-minute. It remains to be seen what elements of the agenda will end up as lasting components of US device regulation, but there is no question that the past year has been a period of regulatory innovation, with multiple pilots picking up speed, major reforms announced, and restructurings pursued.
Much of FDA's recent reform plans have been framed as paths to streamlining regulations and supporting the US as a...
