July 13, 2024


Advocacy. Mediation. Success.

Heath Canada reasonable in finding Natco’s indirect comparison to GENVOYA triggered data protection

On July 24, 2020, Justice McHaffie of the Federal Court dismissed Natco’s software for judicial review, locating that Health Canada’s refusal to accept Natco’s Abbreviated New Drug Submission (ANDS) for its tenofovir alafenamide hemifurate (TAF) / emtricitabine merchandise in watch of data safety was affordable: Natco v Minister of Health and Gilead, 2020 FC 788. Specifically, the Federal Court found that it was affordable for Health Canada to obtain that data safety precluded the filing of…
By: Intelligent & Biggar