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Drug Safety: FDA Needs to Further Address Shortcomings in Its Postmarket Decisionmaking Process: Testimony Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives
Marcia Crosse (au)
Statement of Marcia Crosse, Dir., Health Care, GAO. In 2004, several high-profile drug safety cases raised concerns about the Food & Drug Admin.’s (FDA) ability to manage postmarket drug safety issues. In some cases there were disagreements within FDA about how to address these issues. GAO was asked to testify on the effectiveness of FDA’s postmarket decision-making process. This testimony is based on the GAO report, “Drug Safety: Improvement Needed in FDA’s Postmarket Decisionmaking & Oversight Process,” which focused on the complex interaction between the two offices within FDA that are involved in postmarket drug safety activities: the Office of New Drugs (OND), & the Office of Drug Safety (ODS). OND’s primary responsibility is to review new drug applications, but it is also involved in monitoring the safety of marketed drugs. ODS is focused primarily on postmarket drug safety issues. ODS is now called the Office of Surveillance & Epidemiology.
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