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Missed Review Deadlines Are Reminder That On-Time Approvals Are A Goal, Not A Guarantee

 
• By Bridget Silverman

After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.

• Source: Alamy

The Pink Sheet has identified seven novel agents, at least three biosimilars, and four products with breakthrough therapy designations among the 25 applications with reviews that are continuing past their user fee goal dates. (See table below for details.)

Several of those applications are for JAK inhibitors; for more on the review issues in that class, see the sidebar...

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