Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

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.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS079484

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

Cancel