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Accelerated approval

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FDA
When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for confirmatory trials for therapies seeking the shortened path to market.
January 7, 2025
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3 min read
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Heather McKenzie
Regulatory
Deep Dive: FDA’s Accelerated Approval Pathway Under Fire
In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.
November 18, 2024
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2 min read
 · 
Heather McKenzie