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  • FDA Teams Up With EU Regulators to Launch New Pharmaceutical Quality Initiative

    The US Food and Drug Administration (FDA) has announced a new initiative meant to improve the quality of pharmaceutical products by working more closely with a small group of trusted global regulators. Background Millions of US consumers take pharmaceutical products that originate-either in whole or in part-from foreign countries. And while FDA's budget for inspections has increased in recent years, trends in globalization have left it unable to inspect all manufacturin...
  • Top FDA Regulatory Official Stepping Down, Will Assume New Duties

    The US Food and Drug Administration's (FDA) top regulatory affairs official, Dara Corrigan, is giving up her duties and assuming a position as director of FDA's Europe Office and as senior advisor for global operations, sources tell Regulatory Focus . Corrigan had served as the associate commissioner for regulatory affairs since September 2010, where she was in charge of more than 4,000 staff focused on ensuring regulatory compliance in import, export and manufacturing ...
  • Report: 'Track and Trace' Anti-Counterfeiting Provisions Likely Casualty of User Fee Markup

    • 25 April 2012
    A long-awaited and much-called-for plan to introduce a 'track and trace' plan to cut down on pharmaceutical counterfeiting may be cast by the wayside in the legislative markup process for new legislation, reports Reuters ' AlertNet . Track and trace programs, used by regulatory authorities to keep track of authentic drugs and trace their transmission through the supply chain, have been receiving increased attention in recent years. The US Food and Drug Administrati...
  • Corrigan: FDA Transforming to a Global Agency, Success Depends on Partnerships

    The US Food and Drug Administration's (FDA) Associate Commissioner for Regulatory Affairs, Dara Corrigan, testified Wednesday (28 March) before a House subcommittee investigating drug counterfeiting, saying she believes FDA is moving to become an agency with a global focus built upon global partnerships. Speaking before the House Committee on the Judiciary's Subcommittee on Crime, Terrorism and Homeland Security, Corrigan said FDA "intend[s] to further transform FDA over...