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FDA, OTC Industry Look To Protect Supply Chain Security From Global Threats

This article was originally published in The Tan Sheet

Executive Summary

FDA and the pharmaceutical industry have some catching up to do to mitigate the import safety and counterfeiting risks amplified by the globalization of supply chains, says the agency's policy chief

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FDA overseas offices open by year-end

Health and Human Services Secretary Mike Leavitt lays out a timeline Oct. 16 for opening and staffing foreign FDA offices to work with local authorities and industries that export to the U.S. China will be first, with FDA staffers slated to begin in Beijing by the end of 2008 and other offices opening in Shanghai and Guangzhou next year. FDA also will open an office in New Delhi, India, in 2008. "Opening these offices will mark a key milestone in the globalization of our efforts to enhance the safety of imported food and medical products," Leavitt says. Working closely with foreign regulators is a large component of FDA's Import Safety Action Plan, but dietary supplement industry stakeholders have warned that overseas offices will siphon resources from other agency programs (1"The Tan Sheet" Oct. 13, 2008, p. 12 and 2"The Tan Sheet" Feb. 11, 2008, p. 3)

FDA overseas offices open by year-end

Health and Human Services Secretary Mike Leavitt lays out a timeline Oct. 16 for opening and staffing foreign FDA offices to work with local authorities and industries that export to the U.S. China will be first, with FDA staffers slated to begin in Beijing by the end of 2008 and other offices opening in Shanghai and Guangzhou next year. FDA also will open an office in New Delhi, India, in 2008. "Opening these offices will mark a key milestone in the globalization of our efforts to enhance the safety of imported food and medical products," Leavitt says. Working closely with foreign regulators is a large component of FDA's Import Safety Action Plan, but dietary supplement industry stakeholders have warned that overseas offices will siphon resources from other agency programs (1"The Tan Sheet" Oct. 13, 2008, p. 12 and 2"The Tan Sheet" Feb. 11, 2008, p. 3)

FDA overseas offices open by year-end

Health and Human Services Secretary Mike Leavitt lays out a timeline Oct. 16 for opening and staffing foreign FDA offices to work with local authorities and industries that export to the U.S. China will be first, with FDA staffers slated to begin in Beijing by the end of 2008 and other offices opening in Shanghai and Guangzhou next year. FDA also will open an office in New Delhi, India, in 2008. "Opening these offices will mark a key milestone in the globalization of our efforts to enhance the safety of imported food and medical products," Leavitt says. Working closely with foreign regulators is a large component of FDA's Import Safety Action Plan, but dietary supplement industry stakeholders have warned that overseas offices will siphon resources from other agency programs (1"The Tan Sheet" Oct. 13, 2008, p. 12 and 2"The Tan Sheet" Feb. 11, 2008, p. 3)

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