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...
Just three years after Fresenius Kabi agreed a $4.75bn takeover of the US injectables specialist, Akorn has obtained approval from a US bankruptcy court for its sale to the company’s existing lenders, having filed for Chapter 11 bankruptcy earlier this year.
Dr Reddy’s has announced the launch of its OTC versions of Pataday olopatadine solution in the US. The firm’s entry into the OTC eyecare space follows other OTC launches of rivals to Voltaren and Nicorette earlier this year.
A number of anti-TIGIT drugs are jockeying for position to provide benefit as monotherapies and in combinations for non-small cell lung cancer and Merck's offering is looking to challenge Roche's tiragolumab for the lead.