Researchers Sanket Dhruva and Rita Redberg on the hornet's nest they stirred up with their study of the Food & Drug Administration's approval process for high-risk cardiovascular devices.
It's not often that a few doctors ensconced in the ivy towers of academia can get a lumbering dinosaur like the Food & Drug Administration to turn on a dime, let alone during the week between Christmas and the new year.
But that's exactly what University of California at San Francisco researchers Sanket S. Dhruva, Lisa Bero and Rita Redberg did after the Journal of the American Medical Assn. published their paper "Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices."