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

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

Executive Summary

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.

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.

Are Orphan Incentives Necessary For Development? Sponsors Aren't So Sure

Drug sponsors tell US GAO that orphan incentives don't draw them to the space, and several stakeholders say high prices and scientific discovery are the reason for the sector's growth.

Moxidectin Sponsors Credit PRV Program For Enabling River Blindness Approval

Medicines Development for Global Health is the first nonprofit to earn a priority review voucher for bringing a neglected tropical disease therapy to US approval. Project carried on research from the Wyeth era.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS122612

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