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FDA safety reporting consolidation

Executive Summary

FDA will be consolidating all safety signal reporting systems as part of the formation of its bioinformatics board, Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb says June 21 at the Bank of America Washington Healthcare Conference. Currently, safety reports are received via five or six different systems and, consequently, "they get evaluated very differently and there is no intelligent screen built in through software to try to do an initial evaluation of some of the signals we get," he explains. FDA is currently working on an upgrade to its adverse event reporting system (1"The Pink Sheet" Feb. 13, 2006, p. 4)...

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