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

Pediatric Cancer Study Requirements Added To FDA User Fee Bill

Executive Summary

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.

Advertisement

Related Content

Orphan Pediatric Loophole To Be Closed By US FDA
User Fee Bill Or Drug Pricing Bill? House Members Makes Both Cases
FDARA Would Trim $72 Million From Deficit Over 10 Years, CBO Says
User Fee Reauthorization: 'Pre-Conferenced' Bill Aims For Quick Passage
FDA User Fee Bill: House Cmte. Makes Technical Changes, Adds Pricing Resolution
Off-Label Discussion, But No Additions, For House User Fee Bill
Rare Disease OPEN-ing In PDUFA Possible For Drug Repurposing Advocates
Pediatric Study Requirements For Cancer Have FDA Support, But Pose Industry Challenges
FDA's Orphan Drug Exclusivity Policy May Face Second Court Challenge

Topics

Advertisement
UsernamePublicRestriction

Register

PS121085

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