Mathieu Gagné

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When is Software a Medical Device?

Canada - February 8 2019 Health Canada recently released a draft guidance document on software as a medical device (SaMD). This guidance is intended to help industry better…

Jean-Raphaël Champagne, Dara Jospé, Timothy M. Squire

The Quebec Patient Financial Assistance Ban is Here

Canada - March 31 2021 On March 31, 2021 the Government of Quebec published the final Regulation restricting financial assistance to patients (this PDF is only available in…

Jean-Raphaël Champagne, Denis Douville, Dara Jospé

Innovative Medicines Canada (formerly Rx&D) releases a New Code of Ethical Practices

Canada - February 29 2016 On January 4, 2016, Rx&D formally changed its name to Innovative Medicines Canada and more recently, it updated the Code of Ethical Practices (PDF)…

Dara Jospé

Quebec Court of Appeal Renders Major Decision on the PMPRB

Canada - February 21 2022 In a much-anticipated decision, which will likely have a substantial impact on the pharmaceutical industry in Canada, the Quebec Court of Appeal…

Dara Jospé

Drug Manufacturer’s Duty to Inform: An Analysis of the Brousseau v. Abbott Laboratories Limited Case

Canada - June 5 2019 On May 8, 2019, the Quebec Court of Appeal rendered an important judgment regarding pharmaceutical manufacturers' duty to inform. Facts The…

Jean-Raphaël Champagne, Dara Jospé, Geneviève Laliberté