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

Voucher Does Not Guarantee A Priority Review, FDA Says

Executive Summary

Final guidance on the tropical disease priority review voucher program says FDA will adhere to priority review goals, which allow agency to complete some outside the stated time frame.

You may also be interested in...



Shaping A Shkreli Bill: Voucher Abuse Solution May Stumble On FDA Effects

House bill that would require new clinical studies from sponsor for tropical disease priority review vouchers met with industry concerns about limiting the US agency's flexibility.

Gilead Buys Its Third Priority Review Voucher, But Is The Mania Over?

Just as the tulip craze eventually subsided, it appears the pharma industry's infatuation with priority review vouchers also may be waning, as Sarepta sells its voucher for only $125m.

Sponsors May Race For Rare Pediatric Voucher Designations As Deadline Nears

US FDA program's new 2020 sunset could create a bolus of designation requests to ensure they can still get a voucher if it ends.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119265

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