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Advisory Committee Disagreement With US FDA On Approval Decisions An Increasingly Rare Event

 
• By Derrick Gingery

A new study finds the agency only approved a product despite a negative advisory committee vote six times in six years. The overall rate of agreement between the agency and advisory committees has increased since 2015.

Agreement
FDA-advisory committee agreement was higher among priority applications compared to standard applications. • Source: Shutterstock

The shock and outrage in some circles over the US Food and Drug Administration’s surprise accelerated approval of Biogen, Inc.’s Alzheimer’s treatment Aduhelm (aducanumab-avwa) in 2021 stemmed partly from the agency’s disagreement with its outside advisers, an already uncommon event that data suggests is becoming even more rare.

A study by 3D Communications of all FDA advisory committee votes and drug, biologic and device application decisions from 2017...

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More from US FDA Performance Tracker

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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More from Regulatory Trackers

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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
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Global Pharma Guidance Tracker - April 2025

 
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