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Safety Events For Accelerated Approval Drugs Highlighted As Expansion Looms

 
• By Michael Cipriano

US drugs with accelerated approval are more likely to experience a postmarket safety event, JAMA study finds; data sharing could be a solution to filling information gaps.

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Amid the ongoing expansion of the US FDA's accelerated approval program via the 21st Century Cures Act, safety events for drugs approved through the pathway have been prominent throughout the twenty-first century according to a study.

Postmarketing events were statistically significantly more frequent among novel drugs and biologics approved between 2001 and 2010 that garnered accelerated approval, corresponding author Joseph Ross of the Yale University School of Medicine writes in a JAMA study published May 9, which

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