Pink Sheet 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

UsernamePublicRestriction

Postmarket Drug Safety Surveillance: Updates On Sentinel, OMOP Projects

Executive Summary

FDA is making progress on creating a common language that would allow for drug safety queries in disparate database sources linked to a national Sentinel network, according to FDA Office of the Commissioner Senior Policy Analyst Melissa Robb

You may also be interested in...



Sentinel Initiative's Potential Shortcomings Illuminated At Avandia Panel

The recent Avandia safety panel meeting - during which two FDA advisory committees were unswayed by the results of an observational study by one of the agency's own scientists - underscores the challenges that FDA's Sentinel Initiative will have in becoming an essential regulatory tool

Sentinel Initiative's Potential Shortcomings Illuminated At Avandia Panel

The recent Avandia safety panel meeting - during which two FDA advisory committees were unswayed by the results of an observational study by one of the agency's own scientists - underscores the challenges that FDA's Sentinel Initiative will have in becoming an essential regulatory tool

"Mini Sentinel" With Harvard Gets FDA Halfway To Health Record Target

FDA's four-year, $72 million contract with Harvard Pilgrim Health Care Inc. will create a database that eventually incorporates 60 million health records. The system will bring FDA more than halfway towards its statutory goal of being able to analyze data from 100 million patients

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS052403

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

Cancel