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By Katie Lee
On June 10, 2019, the Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals)and Regulations Amending the Medical Devices Regulations
By David Schwartz
On July 10, 2019, the government of Canada published the final version of the new Patent Rules, which will come into force October 30, 2019.
By Katie Lee
Most interlocutory decisions under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) are made by prothonotaries of the Federal Court (FC).
By Urszula Wojtyra
The Federal Court struck Novo Nordisk's judicial review application challenging the decision of the Minister of Health to accept for review an Abbreviated New Drug Submission (ANDS)
By Abigail Smith
On July 2, 2019, the PMPRB Steering Committee on the Modernization of Price Review Process Guidelines released its final report summarizing
By Urszula Wojtyra
The Canadian Agency for Drugs and Technologies in Health (CADTH) released Issue 8 of its Pharmaceutical Reviews Update announcing updates
By Lynn Ing
Health Canada released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs on June 28, 2019
By Brandon Heard
On June 27, 2019, Health Canada published Drug and medical device highlights 2018: Helping you maintain and improve your health, an annual highlights report for 2018.
By Abigail Smith
On July 5, 2019, Health Canada announced a consultation on its new draft guidance: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products.
By Katie Lee
On June 21, 2019, Bill C-97 received Royal Assent. Bill C-97 includes amendments to the Food and Drugs Act, including a new framework for "Advanced Therapeutic Products"
By Urszula Wojtyra
On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB or Board) and returned to the Board the matter of whether the invention of the 237
By Mark Evans, Tierney Deluzio
On July 22, 2019, the Federal Court issued its decision in Loblaws Inc v Columbia Insurance Company, 2019 FC 961. Pampered Chef, a Berkshire Hathaway company and a world-leader
By Nancy Pei
There have been two Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) decisions on the merits so far in 2019 and a pair of appeal decisions
By Nancy Pei
As of June 30, Health Canada had approved 16 biosimilars, based on 11 comparator products (3 in 2019).
By Nancy Pei
On June 12, the Advisory Council on the Implementation of National Pharmacare released its final report which recommends that Canada implement a universa