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FDA Drug Safety Bulletin Being Considered To “Streamline” Communication

This article was originally published in The Tan Sheet

Executive Summary

Implementation of an FDA standard drug safety bulletin will be one area of focus for the agency's new Associate Director for Safety Policy & Communication Paul Seligman

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Center for Drug Evaluation & Research Director Stephen Galson announces he will appoint a new associate center director "to focus on broad drug safety policy and safety communication" as part of the planned reorganization of the center in a staff memo Nov. 4. The memo provides an update to the proposed CDER reorganization that Galson announced Oct. 19 in conjunction with the appointment of a new Office of Drug Safety head. "Consolidating certain drug safety-related activities to report to this new associate center director" was also suggested by Galson in the update. In addition to drug safety goals, Galson hopes CDER will embrace the Critical Path Initiative and "improve regulatory and drug development science." His suggestions include creating a new office that will report to the center director and "provide a locus in the center to catalyze Critical Path activities." In the memo, Galson announces the appointment of Paul Seligman, MD, to associate center director...

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