Drug Safety: Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process
GAO-report-on-FDA.pdf | 784.2 KB
March 1, 2006
FDA lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues. The process has been limited by a lack of clarity about how decisions are made and about organizational roles, insufficient oversight by management, and data constraints. GAO observed that there is a lack of criteria for determining what safety actions to take and when to take them.