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A User Guide To FDA’s Expedited Programs For Serious Conditions

 
• By Sue Sutter

A handy side-by-side chart shows the criteria, advantages and timelines for the fast-track, breakthrough therapy and priority review designations and the accelerated approval pathway.

Please click here for a quick reference guide providing an overview of key elements of FDA’s four expedited drug development and review programs, including qualifying criteria, features and benefits, timelines and other considerations for sponsors.

The chart was adapted by “The Pink Sheet” from FDA’s May 2014 final guidance, “Expedited Programs for Serious...

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COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
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