Pink Sheet is part of the Business Intelligence Division 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


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

Executive Summary

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

Orphan Designations For Pediatric Subgroups Of Common Diseases To End
Orphan Drug Pricing And Reimbursement: Challenges To Patient Access
Orphan Drug Pricing Doesn't Drive Healthcare Costs, NORD Argues
Orphan Pediatric Loophole To Be Closed By US FDA
Orphan Drug Pricing Heading To Negotiating Table in US?
CDER Director Woodcock Plans Changes To Drug Reviews During OND Transition
Rare Disease OPEN-ing In PDUFA Possible For Drug Repurposing Advocates
Time For Big Pharma To Take Back Orphan Drugs
Biosimilars: Postmarketing Data Alone Not Enough For Interchangeability
Disease 'Subsetting' Not Driving Jump In Orphan Designations, US FDA Says


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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