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

Review Voucher Program For Rare Pediatric Diseases Should Not Be Reauthorized, US FDA Says

This article was originally published in SRA

Executive Summary

More time is needed to gauge whether the US Food and Drug Administration's rare pediatric disease priority review voucher program has actually encouraged the development of new treatments, the Government Accountability Office believes. The FDA, however, isn't interested in giving the incentive program any more time to try to prove itself.

You may also be interested in...



Rare Pediatric Disease Priority Review Voucher Not Generating New Drug Trials

Researchers find no significant difference in number of rare pediatric disease treatments starting clinical development before or after incentive was created, but advocates aren't ready to give up on the program yet.

Rare Disease Supporters Suggest Permanent PRV Program, Even If It May Concern FDA

Non-profit biotech founder says permanent pediatric rare disease priority review voucher program will boost incentive, but FDA is concerned about resource drain vouchers cause.

Orphan Incentives: Voucher Price Drop Gives Some Sponsors 'Pause'

Is the lower sale price making the opportunity for a priority review voucher less an incentive for orphan development?

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS118565

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