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Accelerated Approval: Avastin, Makena Bookend A Watershed Decade For US FDA’s Expedited Pathway

 
• By Sue Sutter

Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.

Vintage books enclosed by old fashioned bookends with a moody dark background
Avastin and Makena became bookends for US FDA's accelerated approval program in the last decade. • Source: Shutterstock

When it comes to the US Food and Drug Administration’s accelerated approval program, the most recent decade ended much the way it started – with the agency weighing whether to withdraw an approval under the expedited pathway.

In 2010, the FDA sought withdrawal of the breast cancer indication for Genentech Inc.’s Avastin (bevacizumab) for failure to...

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