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Delayed Advisory Committees Need Not Worry Sponsors Too Much

 
• By Bridget Silverman

US FDA advisory committee meetings held in close proximity to user fee goal dates are approved at a similar rate to all products reviewed by the advisory panels, according to a Pink Sheet analysis of drug and biologic advisory committees since 2015.

Light bulb in hand with brain

With the COVID-19 pandemic preventing the public advisory committee meetings that play a key role in the US FDA review process for many drug and biologic applications, more sponsors are likely to face a circumstance that occurs in only about 15% of meetings with votes on product approval: an advisory committee meeting date that falls near the user fee goal date.

Fortunately, a Pink Sheet analysis of advisory committee meetings since January 2015 suggests that the prospects of approval are similar regardless of when the meeting takes place in the review...

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