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

 
• By Bridget Silverman

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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User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 
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EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
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What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
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More from Pathways & Standards

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.