The US Food and Drug Administration (FDA) has developed a $25 million per year programme to update the science underlying its safety evaluations, FDA Commissioner Margaret Hamburg announced yesterday.
The new Advancing Regulatory Science Initiative will tackle projects such as modernizing ways to track bacteria in the food supply, developing computer models for toxicology testing, and improving laboratory assays that could facilitate the development of generic drugs. Earlier this year, the FDA launched the initiative by embarking on a collaboration with the US National Institutes of Health.
The initiative follows a critical 2007 report by an FDA advisory board that said the agency was unable to fulfill its mission because its scientific base had eroded. “FDA’s inability to keep up with scientific advances means that American lives are at risk,” the board reported.
Funding for the Regulatory Science Initiative was included in President Obama’s proposed $4 billion FDA budget for fiscal year 2011. But that budget has not yet been approved and funding is currently held at 2010 levels.
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