Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Orphan Designations For Pediatric Subgroups Of Common Diseases To End

19 Dec 2017

• By Derrick Gingery

FDAEntrance_1200x675

Related Content

Keytruda's New Tissue-Agnostic Indication Could Prompt Orphan Policy Changes

17 Oct 2017

ICH Expansion To Bring New Challenges For Global Consensus On Pediatric Extrapolation

24 Oct 2017

US FDA Doesn't Support Creating Ultra-Orphan Designation

20 Dec 2017

US FDA Outlines Streamlined Development Path For Targeted Therapies

16 Dec 2017

Orphan Pediatric Loophole To Be Closed By US FDA

13 Sep 2017

Pediatric Cancer Study Requirements Added To FDA User Fee Bill

12 Jul 2017

Orphan Incentives: Voucher Price Drop Gives Some Sponsors 'Pause'

19 Dec 2017

PDUFA VI: Pediatrics Group Seeks Earlier And Faster Studies

17 Mar 2017

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

08 Mar 2017

Disease 'Subsetting' Not Driving Jump In Orphan Designations, US FDA Says

28 Nov 2016

Additional Topics

United States FDA Rare Diseases Regulation Review Pathway BioPharmaceutical

More from US FDA

More from Agency Leadership

Twitter feed RSS feed RSS feed

About UsOpens in new window
Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us
Customer Service
Subscribe
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window

Copyright © 2025 Pharma Intelligence UK Limited (Citeline), a Norstella company Pharma Intelligence UK Limited is a company registered in England and Wales with company number 13787459 whose registered.