Estimated FDA User Fee Review Goals For Pending NDAs/BLAs
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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...
Scrip M&A Podcast: Which Companies Could Be Acquired Next?
The editorial team from Scrip discusses the M&A potential of various emerging biopharmas, such as Viking, Verona, Altimmune, Xenon and Crinetics.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
P&G Restores Volume Growth In Beauty, Grooming After Pricing Run
Procter & Gamble reports strong consumer spending in the US and Europe after a 3% increase in product pricing over the past year. Dragging on fiscal third-quarter results, sales of SK-II in China fell 30% for the January-March period, while lower incidence of cough and cold impacted Health Care performance.