ePT--the Electronic Newsletter of Pharmaceutical Technology, Feb 3, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Feb 3, 2011
News
President Obama's State of the Union Address Favorably Received by Pharma Industry
By Patricia Van Arnum
President Barack Obama's State of the Union address, delivered last week on Jan. 25, 2011, to the US Congress, was largely well received by the pharmaceutical and biotechnology industries.
EMA Releases Revised Computerized Systems Annex to GMP Guide
By Angie Drakulich
The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.
Senators Reintroduce Bill to Curb Pay-for-Delay Settlements
By Erik Greb
Last Friday, Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced their "Preserve Access to Affordable Generics Act," which would presume that pay-for-delay settlements were illegal and give the Federal Trade Commission (FTC) the power to block them.
Week of Jan. 31, 2011: Company and People Notes: Pfizer Completes King Tender Offer; Cook Pharmica Names VP of R&D and CSO; and More.
Company and People Notes: Pfizer Completes King Tender Offer; Cook Pharmica Names VP of R&D and CSO; and More
Regulatory Roundup: FDA Holds Workshop on Orphan Drugs
FDA Holds Workshop on Orphan Drugs

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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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