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Avastin’s Legacy May Be Quicker Withdrawal Process For New Approval Pathways

 
• By Sue Sutter

CBER Director Karen Midthun, who served as the FDA commissioner’s designee for the hearing on bevacizumab’s breast cancer claim, says the Avastin proceedings required “tremendous resources and time.” Consequently, any new drug approval route should include a mechanism for abbreviated withdrawal, she says.

The resource-draining experience of revoking Avastin’s breast cancer claim means that any new expedited or “progressive approval” pathway should include a quicker, easier withdrawal mechanism, according to Center for Biologics Evaluation and Research Director Karen Midthun.

Speaking at Elsevier Business Intelligence’s FDA/CMS Summit on Dec. 8, Midthun suggested that the agency’s resources should be taken into consideration when it comes to creating a mechanism to quickly...

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• By Vibha Sharma

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