Accelerated Approval May Support Smaller Trials In Acute Diseases – FDA
Final guidance on expedited regulatory pathways suggests FDA is open to accelerated approval for some acute conditions; agency also provides examples outside of HIV/cancer arena where surrogate and intermediate clinical endpoints have supported approval.
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FDA should write more about its interpretation of regs and apply it more consistently across divisions, commissioner says.
Letter being circulated by Rep. Bilirakis states the agency’s draft expedited approval guidance does not provide clarity for rare disease sponsors to use accelerated approval.
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.