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FDA Notifies Genentech of Violations at Avastin Plant
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Erik Greb
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On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.
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GlaxoSmithKline Agrees in Principle to $3-Billion Settlement with the US Government
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| By
Stephanie Sutton
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GlaxoSmithKline has come to a tentative agreement with the US government to conclude ongoing investigations relating to sales and marketing practices. The settlement is still subject to negotiation, but GSK expects to pay around $3 billion, which is covered by existing legal provisions. The final amount and terms of the settlement are expected to be finalized in 2012.
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SOCMA Lends Support for Measures Addressing Nontariff Barriers
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Patricia Van Arnum
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The Society of Chemical Manufacturers and Affiliates issued a statement to support a recently introduced bill that it says will allow the federal government to more effectively deal with market-access barriers.
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EMA Eyes Ophthalmic Medicines
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Stephanie Sutton
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Seeking to review the regulatory and scientific challenges in developing ophthalmic medicines, the European Medicines Agency has recently, and for the first time, brought together eye-disease experts from Europe, Asia, and the US for a two-day workshop.
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Week of Nov. 7, 2011: Procter & Gamble and Teva Pharmaceutical Industries Enter into Consumer Healthcare Partnership; USP Makes Several Executive Appointments; and More
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Procter & Gamble and Teva Pharmaceutical Industries Enter into Consumer Healthcare Partnership; USP Makes Several Executive Appointments; and More.
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Regulatory Roundup: EMA Issues Concept Paper for Public Consultation on Development of Toxicological Guidance for use in Risk Identification
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EMA Issues Concept Paper for Public Consultation on Development of Toxicological Guidance for use in Risk Identification.
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