Home » GAO: FDA Needs Deadline to Increase OSE Postmarket Surveillance Authority
GAO: FDA Needs Deadline to Increase OSE Postmarket Surveillance Authority
December 11, 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.