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Angie Drakulich was editorial director of Pharmaceutical Technology.
August 02, 2007
A US delegation of health officials is visiting China this week on a fact-finding mission regarding food and drug safety.
Did you know that only one-third of prescribed pediatric drugs have been studied or labeled for pediatric use? The Best Pharmaceuticals for Children Act (BPCA) was enacted in 2002 to improve this statistic by providing companies with six months of additional marketing exclusivity if they conduct pediatric trials. The Government Accountability Office recently issued a report that examined data from studies conducted between 2002 and 2005 for drugs specified by the US Food and Drug Administration under BPCA.
Industry and regulatory experts provide advice on inspection preparation and best practices.
July 19, 2007
The IBM Corporation signed a $1.4-billion global outsourcing deal with AstraZeneca PLC (London). The seven-year agreement, which renews and expands on a current contract, covers the provision of IT infrastructure services to 60 countries and additional functions within AstraZeneca.
July 12, 2007
The People?s Republic of China executed one of its former drug safety chiefs, Zheng Xiaoyu, for taking bribes to approve untested pharmaceuticals, including some medicines that contained fake ingredients and led to several deaths.
Novartis Vaccines plans to produce approximately 40 million doses of its ?Fluvirin? vaccine for distribution in the United States during the 2007?2008 flu season.