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 new molecular entitites and novel biologic entities and eight months for priority review NMEs and NBEs. Resubmissions with significant new data or analyses have a six-month goal. FDA may extend review timelines by three months.
You may also be interested in...
Illumina announced on 21 September it will buy back Grail, which is planning to commercialize its multi-cancer early detection blood test Galleri in 2021. See what Illumina’s CEO Francis deSouza said about it here.
Yes, Gottlieb’s in there twice; things get complicated when an agency starts to lose credibility.
Newly published data and results presented at ESMO for Amgen’s sotorasib (AMG 510) show relatively long-lasting responses and progression-free survival in lung cancer.