ePT--the Electronic Newsletter of Pharmaceutical Technology, Jun 28, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Jun 28, 2012
News
Roche to Close US R&D Site
By Amy Ritter
Roche announced that it will be closing its R&D site in Nutley, New Jersey, eliminating approximately 1000 positions.
FDA Updates List of Warning Letters
By Susan Haigney
FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research.
EMA Investigates Roche for Deficiencies in Safety Reporting
By Stephanie Sutton
The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.
EMA Finalizes Pharmacovigilance Guidelines
By Stephanie Sutton
The European Medicines Agency has published its first set of finalized guidelines concerning good pharmacovigilance practices.
Week of June 25, 2012: Bend Research, Catalent Enter into Oral Controlled-Release Technologies Pact; Quintiles Expands in China; and More
Bend Research, Catalent Enter into Oral Controlled-Release Technologies Pact; Quintiles Expands in China; and More.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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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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