Fast Track Pathway May Be ‘Poor Man’s Breakthrough’ But It Works

Most requests for the FDA’s less-heralded expedited review designation are based on Phase II or earlier data, and have a greater chance of success than requests for breakthrough designation.

train fast run on railway track in sunny day
The US FDA has approved nearly 70% of fast track requests. • Source: Shutterstock

Fast track status may not have the cachet of some of the the US Food and Drug Administration's newer expedited review programs, but a surge in applications over the past five years shows its staying power.

The FDA received more than 2,200 requests for fast track status between fiscal year 1998 and 2019, agency data shows. After holding steady from 2004-2014 at around 80-100 requests a...

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