1. Pink Sheet

Avastin Withdrawal Showed Accelerated Approval Hearing Process No Easy Task For US FDA

 
• By Sue Sutter

Internal emails show the 2011 hearing on Genentech’s VEGF-inhibitor was taxing for FDA employees, who had to deal with a number of novel issues; the workload is likely to be similarly complex for staff involved in upcoming hearing on Covis’ preterm birth prevention drug Makena.

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MAKENA’S ACCELERATED APPROVAL HEARING, EXPECTED THIS YEAR, WILL LIKELY BE A SIGNIFICANT LIFT FOR FDA STAFF. • Source: Alamy

With the US Food and Drug Administration still strained by the COVID-19 pandemic, the last thing the agency needs is a lengthy administrative proceeding that drains time and resources.

However, that’s the direction in which the agency is headed with the forthcoming public hearing on the Center for Drug...

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