Company news: Baxter and Shire

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The FDA's Division of Drug Marketing, Advertising and Communication hit Baxter Healthcare Corporation with a warning letter for a physician brochure for Aralast NP, expressing concern over “your continued violative promotion of your products.” The agency cited “similar violations” for overstatement of efficacy and unsubstantiated claims of superiority in an April 14, 2009 warning letter and a July 7, 2008 untitled letter, and demanded that the company provide in writing a plan for ensuring against violative promotion in the future.

Shire is sponsoring six inflammatory bowel disease (IBD) fellowships that “will provide a year of training in the management of IBD to physicians who recently completed a fellowship in gastroenterology.” The fellowships will be housed at top medical institutions including Ceders-Sinai in LA, Cleveland Clinic, Mayo Clinic, Mount Sinai, the University of California San Francisco and University of Chicago Medical Center.
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