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    Euro Roundup: Switzerland moves to mitigate split from EU on device regulation

    Switzerland has adopted supplemental provisions to its new Medical Devices Ordinance (MedDO) to soften the impact of its split from the European Union. The action comes as the failure to update a mutual recognition agreement (MRA) erects barriers to trade between Switzerland and the EU.   Swiss medical device manufacturers have enjoyed barrier-free access to the EU single market since 2001. However, the EU refused to consider updating the MRA in light of the new EU ...
  • Timing of Complete Response Letter Disclosure Leads to Investigation into Novo Nordisk

    • 10 December 2013
    Danish pharmaceutical manufacturing giant Novo Nordisk is the target of a new investigation into whether the company provided adequate disclosure to its investors regarding the status of two drug products it had sought approval for from the US Food and Drug Administration (FDA). Background The investigation, first revealed by Novo in a 10 December 2013 press statement, regards the complete response letters (CRLs) sent by FDA to Novo on 8 February 2013 for two products, ...
  • Sterility Violations Form Basis of FDA Warning Letter to Novo Nordisk

    Life sciences manufacturer Novo Nordisk has been sent a Warning Letter from the US Food and Drug Administration for what regulators said were "significant" deficiencies found at the company's Bagsvaerd, Denmark facility. FDA officials said they were particularly concerned about current good manufacturing practice (CGMP) violations found at the firm, which included practice deviations that could have potentially led to product being manufactured under non-sterile condit...
  • WHO's Chan Calls on Regulators to Curb Use of Antibiotics

    World Health Organization Director-General Dr. Margaret Chan spoke before a gathering of delegates from EU Member States on the subject of antimicrobial resistance, calling the matter a "global threat to health" and one requiring the intervention of regulators. Chan praised several EU nations-in particular Denmark-for their work in curbing antibiotic use in otherwise health animals, but noted the problem is a global one requiring a global response. Surveillance, in parti...