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US FDA Argues Very Few Accelerated Approvals Remain On Market Without Confirmation

 
• By Michael McCaughan

Of products that have had accelerated approval for at least a decade, just 6% are still marketed without the promised confirmatory evidence. And those include cases like ‘antibiotics approved for inhalational anthrax, where the lack of confirmatory clinical trial is a good thing.’ FDA’s Corrigan-Curay says.

Pill with security shield
FDA's defense of the current accelerated approval system is revealing itself. • Source: Shutterstock

The US Food & Drug Administration is set to defend the timeliness of Accelerated Approval confirmatory trial conduct with data as it heads into a period of legislative attention to ideas to improve the pathway.

Center for Drug Evaluation & Research Principal Deputy Director Jacqueline Corrigan-Curay led a trio of FDA officials in presenting an overview of the agency’s use of Accelerated Approval during a Reagan-Udall Foundation

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