ePT--the Electronic Newsletter of Pharmaceutical Technology, Jul 7, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Jul 7, 2011
News
FDA Q11 Draft Guidance Available for Comment
By Amy Ritter
FDA issued a draft guidance, entitled "Q11 Development and Manufacture of Drug Substances," which is now available for comment according to a notice published on June 29, 2011, in the Federal Register.
House Committee Expands Investigation into Tainted Heparin
By Amy Ritter
Members of the House Energy and Commerce Committee are expanding their investigation into the 2008 entry of contaminated heparin from China into the United States market.
EMA Welcomes New Directive on Falsified Medicines
By Rich Whitworth
The European Medicines Agency has responded positively to a new directive published in the Official Journal of the European Union addressing concerns over increases in falsified medicines in the supply chain.
Week of July 4, 2011: Sanofi Forms Research Pact with Weill Cornell Medical Center; Steven A. Nichtberger Resigns as President and CEO of Tengion; and More.
Sanofi Forms Research Pact with Weill Cornell Medical Center; Steven A. Nichtberger Resigns as President and CEO of Tengion; and More.
FDA Withdraws Approval for Roche's Avastin
By Stephanie Sutton
An FDA panel has voted unanimously to withdraw approval for Roche's Avastin for use in the treatment of metastatic breast cancer because there is not enough data to support that the benefits outweigh the risks.

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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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Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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