ePT--the Electronic Newsletter of Pharmaceutical Technology, Sep 27, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Sep 27, 2012
News
ISPE Publishes Guidance for Pharmaceutical Quality Laboratory Design
By Amy Ritter
ISPE has published a new guidance titled ISPE Good Practice Guide: Quality Laboratory Facilities, which defines design guidelines for quality laboratories.
Watson Issues Voluntary Recall of Combination Drug
By Patricia Van Arnum
Watson Laboratories has recalled two lots of hydrocodone bitartrate and acetaminophen tablets.
EMA Streamlines Working Parties
By Stephanie Sutton
The European Medicines Agency has abolished its Cell-based Product Working Party and Gene Therapy Working Party, with the aim of improving efficiencies and optimizing the use of available expertise.
Week of September 24, 2012: Mallinckrodt Agrees to Acquire CNS Therapeutics; Sanofi Outlines R&D Restructuring; and More
Mallinckrodt Agrees to Acquire CNS Therapeutics; Sanofi Outlines R&D Restructuring; and More.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
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Expedited reviews of drug submissions
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Reducing drug shortages
31%
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Protecting the supply chain
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Expedited reviews of drug submissions
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More stakeholder involvement
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Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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