Sentinel Pilot Begins Scanning Drug Data, But Device Work Still Exploratory
This article was originally published in The Gray Sheet
Executive Summary
FDA will implement its mini-Sentinel post-market safety surveillance program for the first time, using data from an ongoing randomized trial of a diabetes drug.
You may also be interested in...
Cap On Mini-Sentinel Funds Raised To $135 Mil. To Support Powerful Surveillance Resource
Funds for FDA’s Mini-Sentinel post-market surveillance program were originally capped at $100 million based on projections for a consortium of at least three automated health care data partners to build analysis capabilities for data covering 100 million patients. The project has significantly exceeded those goals.
CDRH Seeks To Expand Public-Private Medical Device Epidemiology Network
FDA hopes the MDEpiNet post-market surveillance program will be fully functional by the end of the year. A May public meeting is planned to catalyze the effort.
Draft User Fee Bills Aim To Streamline And Strengthen Device Regs
Details on draft legislation circulating in the House and Senate.