Arne Carlson argues in a Star Tribune op-ed that delays, rule changes, and a lack of clarity from the U.S. Food and Drug Administration threaten to hurt medical innovation.
The former governor's comments were published Tuesday, the day the FDA official in charge of medical device regulation,
Jeff Shuren, was in town for a town hall meeting with the Minnesota medical device community.
"The FDA must reinstate a culture of balancing patient risk and benefit to find ways to accelerate the innovation process and to halt this trend of slowing down or delaying device reviews," Carlson writes. "The agency must honor its existing agreements with device companies and change the rules only if new science obsoletes an ongoing trial or if there is a proven new safety risk."
Read the entire op-ed
here.
Source: StarTribune