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  • Flurry of Year-End Drug Approvals Makes 2012 Best Year for Approvals Since 1997

    The US Food and Drug Administration (FDA) has ended the year on a high note, approving a flurry of new pharmaceutical products, taking its 2012 approval total to a 15-year high. US regulators approved at least seven high-profile and mostly new drug products during the final two weeks of 2012, including: Varzig (varicella zoster immune globulin preparation) - Cangene Corporation : Approved for reducing the severity of chicken pox infections in high-risk individuals. ...
  • Is FDA on Pace to Beat Its 2011 Drug Approval Numbers?

    The US Food and Drug Administration (FDA) is potentially on pace to approve fewer new drug entities than it did in 2011, according to several sources. An analysis by The Street of the remaining 2012 FDA advisory committees-panels of experts who provide non-binding advice to the agency regarding whether to approve a new drug product-shows just 23 more drugs set to go before US regulators before the end of the year. The list includes Pfizer's anti-rheumatoid arthri...
  • EMA Looks Back on a Tough Year as it Forges Ahead

    Kent Woods wants stakeholders to know he understands: 2011 was a tough year. As Chair of the European Medicines Agency's (EMA) Management Board and head of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Woods has had a front seat to many of Europe's most difficult regulatory problems. The last year saw EMA's long-time Executive Director, Thomas Lönngren, resign in the midst of controversy and a new ED, Guido Rasi, inherit an agency in the midst...
  • China: 2011 Adverse Reaction Report Released

    China's State Food and Drug Administration (SFDA) has released a report detailing the adverse event reports it received during 2011. The report notes events involving anti-infective medicines accounted for the higher number of reports, including cephalosporins (34.8%), penicillin (14%) and quinolones (12.2%). New and serious adverse drug reactions accounted for 17.1% of the total number of reports.  Medical institutions were the primary source for such reports, acco...
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    Autumn 2011 RAC Class

    The Regulatory Affairs Certification Board and the Regulatory Affairs Professionals Society extend sincere congratulations to the 279 individuals who earned their Regulatory Affairs Certification during the Autumn 2011 RAC exam period. Following is the full list of the Autumn 2011 RAC class. RAC Canada Olufemi Adeoye Yverre Bobay Joanna Chan Nancy Gertlar Babak Givehchi Pantea Habibnia ...
  • Sixteen Drugs Identified by AERS as Potentially Having Serious Risks

    Sixteen drugs were identified by the Adverse Event Reporting System (AERS) during the fourth quarter of 2011 and have been flagged by the US Food and Drug Administration (FDA) for further review, the agency said in a statement on its website. The products, which include Fluoroquinolone-based products, Imodium, proton pump inhibitors and Vertex's hepatitis C drug Incivik, were determined to have potential safety issues in FDA's 17 April posting. FDA noted no causal relat...
  • 2011 Drug Shortages Soar to Record Highs

    Last year was a banner year for drug shortages, according to information just released by the University of Utah Drug Information Service . 267 medications experienced shortages during 2011 , topping the previous year's record of 211, and exceeding 2004 levels by 460%. The issue has attracted the attention of both the US Food and Drug Administration (FDA) and President Barack Obama.  The FDA has launched a drug shortages program to work with manufacturers and...