ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 22, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 22, 2011
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HHS and Novartis Dedicate First Cell-Based Flu Vaccine Plant in US
By Erik Greb
Last week, the US Department of Health and Human Services and Novartis Vaccines and Diagnostics dedicated a manufacturing plant that can create influenza vaccine using cultured animal cells instead of the conventional expression system of fertilized eggs.
GAO Recommends Strengthening FDA's Ability to Respond to Shortages
By Amy Ritter
The Government Accountability Office issued a report recommending that FDA's ability to respond to drug shortages be strengthened. The report was released in conjunction with a Senate hearing before the Committee on Health, Education, Labor, and Pensions on Dec. 15, 2011, on the subject of drug shortages.
GPhA Proposes Voluntary Initiative to Address Drug Shortages
By Patricia Van Arnum
The Generic Pharmaceutical Association has proposed a multistakeholder initiative to minimize current and future critical drug shortages. The announcement follows a series of Congressional, executive, and industry response to address the recent problem of drug shortages.
EMA Plans 2012 Workload
By Stephanie Sutton
EMA has unveiled its work program for 2012, which forecasts a slight increase in marketing authorization applications for new medicines compared with 2011. In addition, EMA said that it will, where needed, strengthen the quality, regulatory, and scientific consistency of its assessment process.
Week of Dec. 19, 2011: Boehringer Ingelheim Expands Manufacturing Presence in China; Amgen CEO Kevin W. Sharer Announces Retirement Plans; and More
Boehringer Ingelheim Expands Manufacturing Presence in China; Amgen CEO Kevin W. Sharer Announces Retirement Plans; and More.

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Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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