ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 20, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 20, 2012
News
Pfizer Settles Off-Label Promotion Charges
By Amy Ritter
Pfizer has agreed to pay USD 55 million plus interest to settle charges that Wyeth (acquired by Pfizer in October 2009) improperly promoted the drug Protonix (pantoprazole).
FDA Issues Draft Guidance on Electronic Submissions
By Patricia Van Arnum
FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.
Vivalis and Intercell to Create New Biotechnology Company
By Stephanie Sutton
Vivalis and Intercell have agreed to the terms of a merger to create a new European biotechnology company called Valneva that will specialize in vaccines and antibodies.
Week of December 17, 2012: Malvern Instruments Opens New Applications Laboratory in Brazil; Roche To Invest in Diagnostics Production in Germany; and More
Malvern Instruments Opens New Applications Laboratory in Brazil; Roche To Invest in Diagnostics Production in Germany; 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
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Reducing drug shortages
29%
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Expedited reviews of drug submissions
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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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