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

Rare Disease OPEN-ing In PDUFA Possible For Drug Repurposing Advocates

Executive Summary

OPEN ACT would provide additional six months of exclusivity when existing drugs are approved for rare diseases; congressional debate over the measure could get bogged down in drug pricing issues.

You may also be interested in...



Pediatric Cancer Study Requirements Added To FDA User Fee Bill

User fee legislation headed for a US House vote this week would require pediatric studies of certain molecularly targeted cancer drugs; the requirement, which could apply to some orphan drugs, would not take effect for three years.

User Fee Bill Could Become Ensnared In US Abortion Politics

Amendment defunding Planned Parenthood is one ACA repeal refugee that could hitch a ride with user fee bill, which would be 'problematic,' to say the least, for Democrats.

Orphan Drug Act: Congressional, FDA, NORD Reviews Come Amid Pricing Debate

Republican Senators request US Government Accountability Office quantify law’s impact and assess whether regulatory or legislative changes are needed. FDA plans ‘unbiased’ look at outcomes from law’s incentives, while NORD is developing data on total percentage of drug spending represented by orphan indications.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS120122

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