Priority Review Vouchers: Does Novartis Have User's Regret?
This article was originally published in The Pink Sheet Daily
Executive Summary
Stakeholders are sympathetic to FDA's concerns that voucher program requires diversion of precious resources, but some believe it provides substantial drug development incentive, particularly for small companies.
You may also be interested in...
Pediatric Vouchers Could Limit Adult Rare Disease Development, FDA Says
Agency expands its critique of voucher incentive that it feels is a strain on agency resources.
Priority Review Voucher Expansion Could Be Bad, Program Creator Says
Congress should be cautious about adding categories because more vouchers will mean a lower price for companies who want to sell them, Duke economist Ridley and Novartis exec Régnier argue.
Novartis Takes Stock Of Ilaris For Gout Following FDA's Complete Response Letter
The agency seeks more clinical data on canakinumab in refractory patients after an advisory committee meeting that focused on the drug's potential risks.