Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.

Related Content

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts