Battle Of The Regulators: Comparing FDA's Accelerated Approval And EMA's Conditional Marketing Authorization

In the ongoing comparison between FDA's Accelerated Approval and EMA's Conditional Marketing Authorization, both agencies offer pathways expediting the development and review of therapies for serious or life-threatening diseases with unmet medical needs, providing unique guidance and ultimately accelerating approvals to benefit public health.

Notably, amidst the global COVID-19 pandemic, expedited development pathways have been instrumental, with FDA's Accelerated Approval allowing surrogate endpoints and EMA's Conditional Marketing Authorization assessing positive benefit-risk assessments for provisional approval, facilitating earlier access to therapies addressing urgent medical needs.