A Government Accountability Office (GAO) report shows that the US Food and Drug Administration (FDA) has not met its statutory requirement for inspections every 2 years of US manufacturers of such high-risk medical devices as pacemakers.
In the report, presented at a January 29 hearing before the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations, the GAO said the FDA estimates that it inspects manufacturers of high-risk devices every 3 years and those producing medium-risk devices (such as hearing aids) every 5 years. And while there is no comparable requirement for inspecting plants outside the United States, the FDA estimated that it inspects foreign manufacturers of high-risk devices every 6 years and those making medium-risk devices every 27 years (http://www.gao.gov/new.items/d08428t.pdf).
The subcommittee also received a report from the FDA's Science Board, an advisory panel that reports directly to the agency's commissioner, that said the agency's mission was at risk because financial and personnel resources have not kept up with its workload.
In commenting about the Science Board's report, the Alliance for a Stronger FDA called on Congress and President George W. Bush to address the agency's shortcomings when creating the budget for fiscal year 2009.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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