How FDA should get ahead of an ever-bending curve of innovation
Meeting its public health mandate will mean creating data not only for approval but to support uptake in the relevant populations
As regulators come up for breath now that the pandemic’s grip is loosening, FDA faces questions about what it can retain from that extraordinary period, and how best to retool itself to meet the most pressing upcoming challenges. At heart, the issue is how to prioritize its resources and meet its public health mandate.
“Nobody can continue at the pace we have for the last three years,” said Janet Woodcock, FDA principal deputy commissioner, speaking at a Jan. 8 summit of the UCSF-Stanford Center for Excellence in Regulatory Science (CERSI)...