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Aduhelm’s ‘Complex’ Circumstances Drove Extensive In-House Advice Process Before Accelerated Approval, Cavazzoni Says

Executive Summary

Accelerated approval was considered as option in response to the negative advisory committee vote, but it was not a ‘default,’ CDER officials say. ‘It fit like a glove.’

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Accelerated Approval: Mid-Review Decisions ‘Not The Norm’ But Will Continue, FDA’s Cavazzoni says

Without directly referencing the agency’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm, CDER director Patrizia Cavazzoni defended US FDA’s ability to decide on use of the expedited pathway during an application review, while also stressing the need for earlier planning on evidence generation and confirmatory trials.

US FDA Accelerated Approval Council Proposed: Codifying A Failure?

There is certainly some logic to directing the US FDA to create a council of top managers to assure that the Accelerated Approval pathway is used consistently. But it sure sounds like exactly what the agency did with Aduhelm.

US FDA Communication Ahead Of Major Actions Could Counter Misinformation, Ex-Official Says

Instead of waiting until after regulatory events like COVID boosters and Aduhelm, FDA should describe its decision-making process along the way to help restore public faith in the agency, former deputy commissioner Josh Sharfstein says.

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