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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

Bolar Exemptions in North America
  • Sterne Kessler Goldstein & Fox PLLC
  • USA, Mexico, Canada
  • December 18 2017

Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use

Kymriah, a revolutionary drug to induce treatment remission in recalcitrant cancers
  • Lakshmikumaran & Sridharan
  • USA, Canada
  • October 30 2017

In an unprecedented historic action, the US Food and Drug Administration (FDA) and Oncologic Drugs Advisory Committee (ODAC) unanimously approved

Internet des objets : réduire les risques liés à la sécurité et à la protection de la vie privée dans un monde interrelié
  • Blake Cassels & Graydon LLP
  • USA, Canada
  • October 27 2017

Votre imprimante. Le refroidisseur d’eau. Le thermostat. Qu’est-ce que ces appareils ont en commun? Ils peuvent tous être connectés à l’Internet des