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  • EMA Closed Through Rest of 2012, Agency Announces

    Regulators, it seems, like their vacation as much as the rest of us do. The European Medicines Agency (EMA), the EU's centralized regulatory agency, announced today that it would be closing its offices for the rest of the year beginning on Monday, 24 December 2012. They are scheduled to reopen on Thursday, 3 January 2013-a 10-day break in all. EMA said it would maintain its emergency telephone number at +44 (0)(20 7523 760, but that its staff will otherwise be unavai...
  • GHTF Says Final Goodbyes, Shutters Website

    So long, Global Harmonization Task Force (GHTF). The global medical device harmonization body has finally disbanded, leaving its unfinished work to the International Medical Device Regulators Forum (IMDRF), a successor organization comprised of officials from regulatory agencies-not industry-around the world. The organization had been a mainstay among the regulatory harmonization movement. Formed in 1992 by EU, US, Japanese, Australian and Canadian regulatory and industr...