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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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.
The rival to House Energy and Commerce Committee Chair Frank Pallone’s bill would not set expiration dates for accelerated approvals.