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Interim Order permits import of FDA-approved drug to address Canadian shortage of epinephrine auto-injectors
  • Smart & Biggar/Fetherstonhaugh
  • Canada
  • October 1 2018

Drug shortages are an important issue in the health care system that Health Canada and the industry have been actively trying to address. On August 27


More than a faux pas to use PHOs: The ban on partially hydrogenated oils (PHOs) comes into effect in Canada
  • DLA Piper
  • Canada
  • September 19 2018

On September 17, 2018, Health Canada’s ban on partially hydrogenated oils (“PHOs”) came into effect. It is now illegal for manufacturers to add PHOs


Health Canada invites public comments on new post-market reporting regulations
  • Gowling WLG
  • USA, Canada
  • August 9 2018

The medical device industry in America and perceived shortcomings in the US Food and Drug Administration's ("FDA") approval process have recently come


Health Canada Proposes Mandatory eCTD Formatted Master Files by 2019; Feedback Requested
  • Keller and Heckman LLP
  • Canada
  • June 14 2018

Health Canada has proposed requiring all new Canadian Drug Master Files (DMF) to be submitted in Electronic Common Technical Document (eCTD) format


Probiotic gut (claims) check
  • Gowling WLG
  • Canada
  • May 7 2018

The use of probiotics in foods in Canada has become commonplace but current policy toward probiotic claims is limited. For food producers willing to


Industry objects to FDA's position on soy protein and heart health
  • DLA Piper
  • USA, Canada
  • April 17 2018

In a statement filed with the FDA on March 19, the Center for Responsible Nutrition, which represents the US dietary supplement industry, took issue


Apotex granted damages for delayed FDA approval of two products
  • Smart & Biggar/Fetherstonhaugh
  • USA, Canada
  • February 28 2018

On December 22 2017 the Ontario Superior Court of Justice held that Apotex was entitled to C$11,303,131.80, plus pre-judgment interest, for losses


Apotex granted damages from contract research organization for delayed FDA approval of two products
  • Smart & Biggar/Fetherstonhaugh
  • USA, Canada
  • January 31 2018

On December 22, 2017, Patillo J. of the Ontario Super Court of Justice held that Apotex was entitled to $11,303,131.80, plus pre-judgment interest


Food and Beverage News and Trends
  • DLA Piper
  • USA, Canada
  • January 23 2018

The CDC has issued a warning about a brand of frozen shredded coconut linked to an outbreak of Salmonella that has sickened people in both the US and


Regulators Setting Crosshairs on Unproven Homeopathic Products
  • Bereskin & Parr LLP
  • USA, Canada
  • December 19 2017

Homeopathic products are a growing industry. As more products hit the market, and their popularity increases, regulators in the United States and