Drug safety “virtual” surveillance sought by FDA

Executive Summary

FDA will hold a public meeting to examine the feasibility of public-private partnerships to create a "virtual" product safety surveillance system based on existing datasets and collection activities. Topics will include the creation of "dynamic feedback loops" in which practitioners and patients fuel data collection and are provided with updated information after analysis. FDA is planning to devote user fee resources to overhaul its postmarketing surveillance efforts (1"The Pink Sheet" Jan. 15, 2007, p. 3). The meeting on the "Sentinel Network" will take place March 7-8 at the University System of Maryland Shady Grove Center in Rockville, Md...