Estimated FDA User Fee Review Goals For Pending NDAs/BLAs
This article was originally published in Pharmaceutical Approvals Monthly
User fee goals are calculated based on the date of receipt. For applications submitted Oct. 1, 2012 and later, the timeframes are extended two months, to 12 months for standard review and eight months for priority review applications. Resubmissions with significant new data or analyses have a six-month goal. FDA may extend review timelines by three months.