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Lawmakers Question the Activities of FDA's Puerto Rico Office
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Erik Greb
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The US Food and Drug Administration's Puerto Rico district office "may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," according to Rep. Edolphus Towns (D-NY), chair of the US House of Representatives Committee on Oversight and Government Reform.
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Sanofi and Genzyme Still at Odds Over Acquisition
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Stephanie Sutton
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Sanofi-aventis (Paris) has asked Genzyme to stand aside and let the shareholders decide on whether an acquisition should take place.
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EMA Issues Draft Principles on Postapproval Change Management
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Angie Drakulich
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The European Medicines Agency published a draft list of questions and answers on postapproval change-management protocols last week.
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Biogen Idec Announces Restructuring Program
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Patricia Van Arnum
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The biotechnology company Biogen Idec (Weston, MA) announced last week a major restructuring program that will refocus the company's research and development (R&D) programs, consolidate facilities, and reduce its workforce.
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ODT Market to Exceed $13 Billion by 2015
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Stephanie Sutton
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The market for orally disintegrating and fast dissolving tablets could exceed revenues of $13 billion by 2015 based on upward global growth trends, according to a report from Technology Catalysts International, a technology transfer and business consulting firm based in Virginia.
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Week of Nov. 8, 2010: Company and People Notes: Eli Lilly Acquires Avid Radiopharmaceuticals; EMA Recruiting New Director; and More.
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Eli Lilly Acquires Avid Radiopharmaceuticals; EMA Recruiting New Director; and More
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Regulatory Roundup: PQRI and FDA present Process Drift Workshop, and More.
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PQRI and FDA present Process Drift Workshop, and More.
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