Lifting the ‘Breakthrough’ Veil: FDA Increases Transparency To Reduce Futile Requests
Case studies demonstrating what kinds of drugs do and don’t qualify for the expedited pathway designation will be presented at an April workshop co-sponsored by the Brookings Institution.
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Companies currently face little risk in seeking the designation because there is no financial cost and FDA denial is confidential.
An early, informal conversation between a sponsor and the review division about the supportive data could help reduce the number of ‘breakthrough therapy’ designation requests that are ultimately denied, FDA and sponsors said.
FDA on average sent about 20 more information requests during breakthrough product reviews than others in the Program, according to interim assessment of the PDUFA V review system. Assessment could support higher funding for breakthrough program in next user fee round.