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FDA Commissioner Testifies for PDUFA Reauthorization
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Patricia Van Arnum
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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.
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Pfizer Contraceptive Pill Packaging Error Leads to Recall
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Rich Whitworth
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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.
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EMA to Implement Pharmacovigilance
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Stephanie Sutton
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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.
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GlaxoSmithKline Tracks R&D Performance
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Amy Ritter
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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.
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Week of Feb. 6, 2012: AstraZeneca Restructures; Catalent Completes Expansion in Italy; and More
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AstraZeneca Restructures; Catalent Completes Expansion in Italy; and More.
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Regulatory Roundup: FDA Addresses the Regulation and Approval Process of PET Drugs
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FDA Addresses the Regulation and Approval Process of PET Drugs.
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