FDA Reviews Likely to Slow as COVID-19 Workload Increases

FDA Commissioner Stephen Hahn said the agency is meeting its user fee-related review goals for now during the COVID-19 outbreak, but the agency may not be able to sustain its current workload.

Hahn said the agency is working at full capacity to ensure that the drug programs continue to see minimal interruptions, but it will need to reprioritize if there is an increase in drug shortages or supply disruptions.

“It is difficult to speculate on what the exact impact will be on incoming submissions moving forward,” he said.