ePT--the Electronic Newsletter of Pharmaceutical Technology, Nov 21, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Nov 21, 2012
News
FDA Adopts Final Version of Q11 Guidance
By Amy Ritter
FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.
Janssen, Merck, and Eli Lilly Form Industry Collaboration
By Patricia Van Arnum
The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.
Thermo Fisher Scientific Opens New Manufacturing Facility in China
By Adeline Siew, PhD
Thermo Fisher Scientific has officially opened its new manufacturing facility in Suzhou, China. The $20-million plant will manufacture life-sciences consumables and equipment as well as establish local production capabilities to meet increasing demand in China and other regions in Asia Pacific.
Week of November 19, 2012: German Court Finds AstraZeneca's Seroquel XR Formulation Patent Invalid; FDA Advisory Committee to Recommend Approval of GSK's H5N1 Influenza Vaccine Candidate; and More
German Court Finds AstraZeneca's Seroquel XR Formulation Patent Invalid; FDA Advisory Committee to Recommend Approval of GSK's H5N1 Influenza Vaccine Candidate; and More.
Regulatory Roundup, Week of November 19, 2012
USP announces new drug naming policy and FDA releases two guidance documents.

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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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