Thursday, May 16, 2013

FDA Receptive To Establishing Metrics For Clinical Trials, Says CDRH Entrepreneur


FDA Receptive To Establishing Metrics For Clinical Trials, Says CDRH Entrepreneur-graysheet: Hance, the former president of Abbott Vascular, is among eight outside experts selected last year to work inside CDRH for about six months to identify new approaches to improving the center’s processes, with a focus on three areas: streamlining clinical trials, facilitating reimbursement and better utilizing post-market data in the pre-market setting. An additional five experts have been advising the effort from outside FDA. The 13 experts in total represent the second round of the entrepreneurs-in-residence program. (See "CDRH Entrepreneurs Take Two: Streamlining Data Collection And The Path To Reimbursement" — "The Gray Sheet," Oct. 22, 2012.)