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.