PDUFA VII Talks Begin With Similar Goals For Industry, US FDA
Both sides want enhancements to deal with growth in cell and gene therapy, as well as work on regulatory decision tools and finance issues.
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More patient-centric trial designs also may be coming due to pandemic-related advances, Marks says.
Stephen Hahn also said the expedited approval process could be even more efficient.
In part because assessment costs plummeted in FY 2019, the FY 2021 fee to redeem a priority review voucher will be 37% less than the previous year.