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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Priority Review Costs Remain Stable While Voucher Fee Ticks Up

Executive Summary

Formula was changed to better calculate the cost of a priority review, FDA says.

You may also be interested in...



Priority Review Voucher Program For Rare Pediatric Diseases Extended As FDA Lowers Fee

Next fiscal year will be a good one to redeem a voucher, and probably to qualify for one as well.

Sanofi Diabetes Franchise Could Get Boost From Retrophin’s Voucher

Priority review ticket might be used on Type 2 diabetes combo LixiLan, expected to be filed later this year.

Review Cost For Sanofi/Regeneron’s PCSK9 Inhibitor Remains Uncertain

Even after paying BioMarin $67.5 million for the voucher itself, the firms still don’t know how much FDA will charge for a chance to get Praluent to market faster.

Related Content

Related Companies

UsernamePublicRestriction

Register

PS056340

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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