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

UsernamePublicRestriction
UsernamePublicRestriction

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.

Advertisement

Related Content

Orphan Pediatric Loophole To Be Closed By US FDA
Orphan Drug Pricing Heading To Negotiating Table in US?
Before Price Controversy, Emflaza Got Easy US Nod With Old But Good Enough Data
Deal Watch: Success Nets CytomX Another $200m From BMS, Up To $3.6bn For Milestones
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

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

PS120178

Ask The Analyst

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

All set! This Question has been sent to 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