termsTerm
Project Orbis
Project Orbis is a scheme where the FDA and partner regulators (Australia, Canada, UK, Switzerland, Singapore, Brazil, Israel) review a cancer drug at the same time.
Started 2019; concurrent submission and review shortens the gap between US and partner-country approvals from years to months for many oncology drugs. Not a joint decision: each regulator decides independently.
Regulatory: what this kind of term is about · animated schematic, not to scale
Category
Regulatory