US FDA’s Accelerated Approval Reforms Include Dispute Resolution For Withdrawals
Allowing decisions to be reviewed by higher management levels, rather than convening administrative hearings, could save time in the withdrawal process.
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Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.
As a “laborious” hearing at the Food & Drug Administration on whether to withdraw the accelerated approval for Covis’s pre-term delivery drug Makena, FDA chief Robert Califf commented that industry is not doing enough to provide the evidence required for the fast-track approval pathway.
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.