Dr. Richard Gilfillan, the 1st leader of the recently-created Center for Medicare & Medicaid Services Innovation Center, will hand over the reigns at the end of the month, and no replacement has yet been named.
MASSDEVICE ON CALL — Minnesota medical device lobbying group LifeScience Alley joined forces with FDA regulators to launch the Medical Device Innovation Consortium, a partnership dedicated to advancing regulatory science.
The group will include leaders from medical device groups and the FDA’s Center for Devices & Radiological Health in pursuit of improving the federal watchdog agency’s medtech review process.
Former Medtronic (NYSE:MDT) CEO Bill Hawkins will serve as the first chairman of a new private-public partnership aimed at improving development and testing of medical devices.
The partnership includes the Minnesota med-tech community, the FDA’s Center for Devices & Radiological Health and the University of Minnesota to establish a regulatory science center in the North Star State.
The FDA made it official with LifeScience Alley, a Minnesota-based medical device lobbying group, signing a memorandum of understanding on the continued development of best practices in regulatory science.
At the close of his two-day visit to Minnesota, Dr. Jeffrey Shuren, director of FDA’s Center for Devices & Radiological Health, announced that a new public-private partnership will be formed with trade group LifeScience Alley in efforts toward developing regulatory science, a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices.
"As a country we don’t invest in regulatory science as opposed to basic science or translational science," Shuren said.
MASSDEVICE ON CALL — House Democrats took to the podium this week to point the finger at the GOP for trying to censor Democratic efforts that are critical of Republican Medicare reform.
Democrats say the Franking Commission, which oversees member mailings, blocked communications that weren’t favorable to the GOP’s 2012 budget plan.
Democrats called the Franking Commission’s actions "blatant and transparent censorship."