ePT--the Electronic Newsletter of Pharmaceutical Technology, Feb 9, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Feb 9, 2012
News
FDA Commissioner Testifies for PDUFA Reauthorization
By Patricia Van Arnum
Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to support the fifth authorization of the Prescription Drug User Fee Act, also known as PDUFA V. She also outlined a series of recommendations, sent to Congress in January 2012, to include in PDUFA V.
Pfizer Contraceptive Pill Packaging Error Leads to Recall
By Rich Whitworth
Following a packaging error affecting birth-control pills, Pfizer has issued a one-million pack recall and warned women in the US who have been taking the medication during the last several months to consult with their physicians.
EMA to Implement Pharmacovigilance
By Stephanie Sutton
The European Medicines Agency (EMA) has published an implementation plan for Europe's new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk–benefit monitoring of drugs. The new legislation will represent the biggest change in the legal framework of the industry since EMA was first established in 1995.
GlaxoSmithKline Tracks R&D Performance
By Amy Ritter
GlaxoSmithKline released its fourth quarter and full year 2011 earnings report, which showed its return on R&D to be 12%—up from 11% in 2010, and closing in on the company's goal of a 14% return.
Week of Feb. 6, 2012: AstraZeneca Restructures; Catalent Completes Expansion in Italy; and More
AstraZeneca Restructures; Catalent Completes Expansion in Italy; and More.
Regulatory Roundup: FDA Addresses the Regulation and Approval Process of PET Drugs
FDA Addresses the Regulation and Approval Process of PET Drugs.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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