FDA: Most Sponsors on Track to Fulfill Postmarket Requirements
As of the end of fiscal 2015, postmarket requirements (PMR) were fulfilled for 69 percent of NDAs, marking a slight decline from the previous fiscal year.
In contrast, the PMRs completed for BLAs trended upward in fiscal 2015, after drug sponsors reported completing 90 percent of the FDA’s mandatory trials, compared to 77 percent in fiscal 2014.
The FDA expects 88 percent of PMRs for NDAs will arrive on schedule. Meanwhile, 91 percent of PMRs for BLAs are on track for submission by their deadline, according to an FDA report.