Priority Review Voucher's Uncertain Value May Hinder Development
Executive Summary
FDA’s innovative priority review voucher, intended to incentivize the development of new drugs for neglected diseases, may actually have created a hurdle in some cases.
You may also be interested in...
Tropical Disease Development Partnerships Want More Help From U.S. FDA
The agency’s infrastructure is not attracting many of the Product Development Partnership sponsors, Aeras official says, but new draft guidance could help.
Tropical Disease Development Partnerships Want More Help From FDA
The agency’s infrastructure is not attracting many of the Product Development Partnership sponsors, Aeras official says, but new draft guidance could help.
Ilaris Complete Response Letter Raises Questions About The Validity of Priority Review Vouchers
What’s a Priority Review Voucher worth? That’s a complicated question now that the first voucher used on an application, from drug maker Novartis AG for Ilaris (canakinumab), has received a complete response letter from US regulators.