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Enantiomer not considered innovative drug despite extensive clinical data

  • Borden Ladner Gervais LLP
  • -
  • Canada
  • -
  • December 19 2011

This is a judicial review of the decision of the Minister of Health, refusing to list DEXILANT on the Register of Innovative Drugs

Industry news

  • Borden Ladner Gervais LLP
  • -
  • Canada
  • -
  • October 24 2011

Health Canada is proposing amendments to the Food and Drug Regulations to permit the assessment of the risks associated with the non-medicinal ingredients of Division 1 drugs

Other industry news

  • Borden Ladner Gervais LLP
  • -
  • Canada
  • -
  • July 25 2011

Health Canada released a draft Guidance Document Part III: Consumer Information, Guidance Document: Product Monograph