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HHS, FDA heads in China

This article was originally published in The Rose Sheet

Executive Summary

Health and Human Services Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach are in China the week of Nov. 17 to consult with Chinese counterparts, conduct two workshops and open offices in three cities, HHS says Nov. 13. Last month, Leavitt laid out a timeline for opening and staffing foreign FDA offices to work with local authorities and industries that export to the U.S. FDA staffers are slated to begin in Beijing by the end of 2008; other offices will open in Shanghai and Guangzhou next year. FDA also will launch an office in New Delhi, India, before year's end, Leavitt indicated. Working closely with foreign regulators is a large component of FDA's Import Safety Action Plan. Imported counterfeit toothpaste tainted with diethylene glycol has been on FDA's radar since it ordered the detention of all such products in summer 2007 (1"The Rose Sheet" Sept. 1, 2008, In Brief)

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Tainted toothpaste update

Two men and two corporations pleaded guilty in the U.S. District Court for the Eastern District of New York to charges of trafficking counterfeit Colgate toothpaste, including some that contained diethylene glycol, the Department of Justice announces Aug. 21. Saifoulaye Diallo and Habib Bah, both of New York, and two New York companies, Mabass Inc. and Vidtape Inc., admit to having trafficked a total of 518,028 tubes of the counterfeit Colgate toothpaste, with an estimated retail value of $730,419, and selling the products to secondary distributors and small- to medium-sized discount stores in several states. The products were imported from China, packaged in Colgate-looking trade dress, and did not contain fluoride while some contained microorganisms such as bacillus spores, according to DOJ. Diallo and Habib each face up to 10 years in prison, a $2 million fine and three years' probation after release, DOJ says. U.S. Customs and Border Protection seized more than 1,400 tubes of toothpaste adulterated with antifreeze ingredient DEG in Charleston, S.C. in fall 2007 after FDA ordered the detention of all such products that summer (1"The Rose Sheet" Oct. 8, 2007, In Brief)

EMA Set To Discuss Safety Of Ranitidine Drugs Soon

Following the announcement in the US that ranitidine drugs must be withdrawn from the market, the European Medicines Agency told the Pink Sheet it would decide on the fate of these medicines in the EU after wrapping up its own inquiry.

Coronavirus Update: Supercomputing, Regulatory Flexibilities & Coordinating Supply Strategies

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