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

Voucher Bargain: US FDA Lowers Redemption Fee; NDA And BLA Review Costs Decrease

Executive Summary

Additional fee will be less than traditional PDUFA application fee in FY 2019, meaning voucher redemptions will cost less than double a typical application review.

You may also be interested in...



A 'More Radical Idea': Set Expiration Dates For Priority Review Vouchers

Sanofi executive offers five-year voucher life-span as potential option for sustaining the resale market.

US FDA's Streamlined Hiring Pilot Restarts After Delay

Recruiting for “Cures”-funded positions resulted in two hires, then got an HHS review; onboarding time should be reduced significantly, but finding the money to pay the higher salaries remains a challenge under the new process.

PDUFA Becomes US FDA's Billion Dollar Baby

Second consecutive year of record workload levels drive substantial increase in FDA's prescription drug user fee revenue target for fiscal year 2019.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL016481

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