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GAO: Food and Drug Administration Faces Challenges in Establishing Protections for Its Postmarket Risk Analysis System

Posted on June 2, 2009 by Dissent

 

From the report (pdf):

The Sentinel system is still in the early planning stages, with key decisions about development and milestones yet to be made. In planning for Sentinel, FDA has held outreach meetings with stakeholders, established a senior management team to solicit input from agency components; established a working group to share information with federal partners; and sought input from projects involving both public and private sector entities that are meant to refine research approaches and identify challenges and concerns. Although FDA has developed a preliminary design of the Sentinel process for making medical product safety-related queries (see below), key decisions such as developing a governance model for oversight and enforcement of relevant policies, establishing an architecture, and setting privacy and security policies have not yet been made. Further, FDA has not yet developed a plan or set of milestones for when it expects to have these issues addressed.

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