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Federal Court: Transferring drug submission does not require re-serving Notice of Allegation

Photo of Kristin WallPhoto of Paul JorgensenPhoto of Pardeep Heir
By Kristin Wall, Paul Jorgensen & Pardeep Heir on October 22, 2023

The Federal Court has upheld a decision of the Minister of Health (Minister) that the new owner of a biosimilar new drug submission (NDS) could adopt the notice of allegation (NOA) served by its…

Federal Court finds that Health Canada breached procedural fairness by relying on an undisclosed internal guidance document

Photo of Kristin WallPhoto of Paul JorgensenPhoto of John Greiss
By Kristin Wall, Paul Jorgensen & John Greiss on September 5, 2023

On August 8, 2023, the Federal Court overturned Health Canada’s decision that a cannabis product, Edison Jolts, was to be classified as edible cannabis and not cannabis extract.   The Court found that Health Canada had breached the duty of procedural…

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Stay up-to-date with legal and regulatory developments affecting the pharmaceutical industry. Pharma in Brief provides timely updates with a focus on the key take-away you need to know.

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