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A new strategy released by FDA last week will transform the agency and allow it to act globally to ensure the safety and quality of imported products. Four key elements make up the new strategy, with the first being to partner with international counterparts to set up global coalitions of regulators. These coalitions will then develop global data information systems and networks and increase the sharing of data and regulatory resources. The third component calls on FDA to build in additional information-gathering and analysis capabilities that focus on risk analytics and information technology.Lastly, FDA will increasingly leverageefforts of the public, private third parties, and industry, and allocate agency resources on the basis of risk. Such a strategy is needed because the imports FDA regulates have quadrupled since 2000, according tothe agency.
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