Ropes & GrayยทPHARMA / BIOTECH

EU General Court sets high bar for challenging pharma regulatory decisions

The EU General Court's September 2026 ruling in Case T-455/24 establishes that courts will largely defer to regulators on scientifically complex decisions, with randomized controlled trials holding decisive weight over real-world data.

eu-general-courtpharmaceutical-regulationjudicial-reviewema-chmpclinical-trialsmarketing-authorizationprecautionary-principle
Read the original firm alert โ†’ Thursday, September 24, 2026

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