On the fast track - how safe are we? - The FDA approval process

28 September 2015

How long does it take for a new medicine to be approved by the US Food and Drug Administration? That depends. As with many government agencies around the world, the application and approval process takes many different paths, writes Dr Nicola Davies in her monthly exclusive for The Pharma Letter.

The FDA has a standard approval process with open-ended approval times. However, for medicines and biologics aimed toward serious or life-threatening diseases or where there is currently no known therapy for the illness, the FDA has a three-tiered fast-track system. They are:

Accelerated Approval
Priority Review
Fast Track Acceleration

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