Agency Publishes Notice In March 9 Edition Of The Federal Register: Seeking Public Comment On Proposed Voluntary Survey
(Posted by Tom Lamb at DrugInjuryWatch.com)
In May 2008 the FDA published a white paper, "The Sentinel Initiative - A National Strategy for Monitoring Medical Product Safety", that served to introduce and explain this new agency effort intended to to improve the post-approval monitoring of prescription drugs and medical devices.
In a brief article, "FDA Wants Better Product Monitoring", which appeared in the March 9, 2009 edition of HDM Breaking News we learned the FDA is moving forward with the Sentinel Initiative project:
The Food and Drug Administration is seeking public comment on a proposed survey to support its Sentinel Initiative for monitoring medical product safety....
The new survey is designed to identify data sources that could participate in the Sentinel Initiative. "The proposed system will enable queries of distributed data sources quickly and securely for relevant product safety information," according to a newly published FDA notice. Data will continue to be managed by its owners, and only data of organizations that agree to participate in this system will be included, the FDA says, adding assurance that strict privacy safeguards will be followed.
The FDA estimates that about 250 respondents will participate in the voluntary survey. They will include federal agencies, insurers, health information exchanges, large multi-specialty group practices, large hospital systems, pharmacies, medical societies, consumer-oriented Web sites, research networks, commercial data sets, laboratories and registries.
For those interested in learning information about this voluntary survey concerning possible Sentinel Initiative participants / sources, you can read the FDA's March 9 notice by starting at The Federal Register (FR): Main Page.
We will continue to monitor developments related this FDA Sentinel Initiative project.