Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Priority Review Voucher Program Relies On Perceptions, BVGH Head Warns

This article was originally published in The Pink Sheet Daily

Executive Summary

Coartem may not be perfect test case for advocates of incentive program.

You may also be interested in...

Committee Backs Novartis’ Coartem; May Be First Drug To Earn Priority Review Voucher

Anti-infective advisory committee overwhelmingly approves Coartem’s efficacy and safety, but with a laundry list of post-marketing study and labeling recommendations.

Priority Review Vouchers One Step Closer, But Congress Must Act Again

FDA guidance on incentive for neglected tropical disease research clarifies some key questions—but also stresses need for appropriation authority to make program work.

Novartis Coartem NDA May Lead to First Priority Review Voucher

Malaria drug receives "priority" status from FDA, which should mean Novartis receives a voucher for priority designation on another product under new incentive program for tropical disease research. December application deadline also sets a deadline for FDA to defi ne key elements of how PRVs will work.

Related Content





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts