Regulators discuss accelerated approvals, Project Orbis at DIA

RAPS

16 June 2020 - Regulators from the US FDA, European Medicines Agency and Health Canada gave their perspectives on different issues related to accelerated approval pathways in their respective jurisdictions at the Drug Industry Association’s Global Annual Meeting.

All three regulators offer their own form of accelerated approval based on less comprehensive clinical data than a traditional marketing approval would require. 

In the US, that pathway is dubbed accelerated approval (AA), while the EU version is called conditional marketing authorization (CMA) and in Canada it is referred to as notice of compliance with conditions (NOC/c).

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Michael Wonder

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Michael Wonder