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www.fdanews.com/articles/122869-gao-fda-needs-deadline-to-increase-ose-postmarket-surveillance-authority

GAO: FDA Needs Deadline to Increase OSE Postmarket Surveillance Authority

December 10, 2009
Despite significant increases in staff and use of external advisory committees to conduct drug safety reviews, the FDA’s Office of New Drugs (OND) and Office of Surveillance and Epidemiology (OSE) remain unable to fulfill their responsibilities for postmarket drug safety reviews, a Government Accountability Office (GAO) report says. To address this weakness, the GAO recommends that the FDA develop a comprehensive plan to transfer regulatory authorities from OND to OSE, which the FDA says it will do as soon as that office’s 193 staff has enough training and funding to handle the work, according to the report.
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