CRED Understanding Clinical Development 2024

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08/10/2024

The Organisation for Professionals in Regulatory Affairs

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Support for early access

EU

US

PRIME

Breakthrough Designation

Compassionate use

Fast Track Designation

Accelerated assessment

Priority Review

Conditional marketing approval

Accelerated Approval (AA)

EU Guidance - EU Guidance US Guidance - US Guidance Document; FDA Acceleration options

The Organisation for Professionals in Regulatory Affairs

30

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