Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks
Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.
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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.
Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.
Allowing decisions to be reviewed by higher management levels, rather than convening administrative hearings, could save time in the withdrawal process.