3 ms·
I wonder how much of the delay is due to FDA staffing levels. If they had more staff they can evaluate more trials in parallel?
by pkaye 6y ago
I wonder how much of the delay is due to FDA staffing levels. If they had more staff they can evaluate more trials in parallel?
- nickff 6y agoAccording to the FDA, 2/3 of their spending on human drug regulation is covered by user fees. Given that some or most of the rest must be non-approval related (ongoing supervision and overhead), and the approval work doesn't go away if they delay it, I'd guess that they have the resources to evaluate as many trials as are ongoing. https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glan...
- pkaye 6y agoIn that case the priority review voucher process doesn't make sense if they can evaluate them concurrently.