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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User fee reauthorization negotiators from US FDA and industry divide into subgroups to tackle specific issues before moving to the broader agreement.
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.