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FDA Announces Plan to Launch "Regulatory Science" Initiative


The Food and Drug Administration (FDA) has issued a report titled “Advancing Regulatory Science for Public Health,” that outlines the agency’s plan to develop new scientific and technological tools, standards and approaches to improve its ability to assess the safety, efficacy, quality, and performance of FDA-regulated products, including foods and tobacco. FDA expects to use President Barack Obama’s $25-million increased budget request for fiscal year 2011 to expand the initiative and “build additional partnerships with academia, industry and government around the country.” According to a news source, FDA’s budget has been frozen under a continuing resolution Congress passed before taking its latest recess.

A new office dedicated to regulatory science will be created, and the initiative’s goals include protecting the food supply by focusing on “the development of more rapid and practical methods for detecting microbial pathogens in food and equipping FDA’s labs to test multiple food samples for contaminants at once. In addition, FDA must enhance the scientific understanding of the causes of food-borne illness so that feasible interventions can be designed and implemented to effectively reduce risk.” The report refers to other opportunities “to advance regulatory science to improve food safety,” such as (i) “Developing effective tools and strategies for sampling, testing and analysis,” (ii) “Tracking Salmonella in the food supply,” (iii) “Preventing microbiological hazards,” (iv) “Responding to food-borne illness,” (v) “Controlling toxins,” and (vi) “Monitoring antibiotic resistance in food-borne pathogens.”

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