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 Voucher Program For Rare Pediatric Diseases Extended As FDA Lowers Fee

Executive Summary

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

You may also be interested in...



Priority Review Voucher Fee Rises 4.6% For Fiscal 2018

As of Oct. 1, the fee for rare pediatric disease and tropical disease priority review vouchers will be $2.83m; the increase follows a slight decline in FY 2017.

Drug Pricing Bill May Make Six-Month ANDA Review Slower Than Eight-Month Review

Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.

Drug Pricing Bill May Make Six-Month ANDA Review Slower Than Eight-Month Review

Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119223

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