FDA Will Survey Sources for Sentinel Initiative

The FDA is taking a step forward in its Sentinel Initiative to track the safety of marketed drugs and biologics by preparing to survey potential sources of postmarket information. The FDA Amendments Act of 2007 calls for HHS to link to disparate data sources and establish a postmarket risk identification and analysis system. As a result, the FDA is working to access data on 25 million patients from disparate sources by July 1, 2010, and 100 million patients a year later, according to a notice in the Federal Register.
Washington Drug Letter