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2018 Highlights in Canadian Life Sciences IP
  • Smart & Biggar/Fetherstonhaugh
  • Canada
  • January 7 2019

In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: 1 a June update on biosimilars


Spotlight on Medical Implant Devices Spurs Regulatory Changes
  • Borden Ladner Gervais LLP
  • Canada
  • November 30 2018

In the past few days, there has been increased media attention in Canada and around the world on the safety, efficacy, and regulation of medical


CADTH releases Environmental Scan on International Policies on Use of Biosimilars
  • Smart & Biggar/Fetherstonhaugh
  • Canada
  • November 29 2018

In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies


Multistate E. Coli Outbreak Linked to Romaine Lettuce Grown in California
  • Keller and Heckman LLP
  • USA, Canada
  • November 27 2018

As we reported on this blog last week, FDA and the Centers for Disease Control and Prevention (CDC), along with state and local agencies, were


FDA and CDC Investigate Multistate E. coli Outbreak Linked to Romaine
  • Keller and Heckman LLP
  • USA, Canada
  • November 21 2018

The FDA and the Centers for Disease Control and Prevention (CDC), along with state and local agencies, are investigating a multistate outbreak of E


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