Health and Human Services Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach announce Jan. 15 the agencies have offices established in New Delhi, and Mumbai, India. Ten HHS/FDA officials will be assigned in India "to work closely with industries that ship food and medical products to the United States, to improve safety and quality, which will facilitate the smooth flow of trade," HHS says. FDA also has a presence in China, Central America and Europe. As part of its Beyond Our Borders Initiative, the agency says it will expand in 2009 to Mexico, the Middle East and South America and open additional European sites (1"The Tan Sheet" Jan. 28, 2008, p. 3)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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