Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks?

Feb 04 2020

• By Derrick Gingery

User Fee Reauthorization Preview 2020 — BsUFA III could be designed to help boost growth of the US biosimilar industry. • Source: Pink Sheet Illustration

Related Content

Playing It Safe? Hahn's Biosimilar View

Nov 24 2019

FDA's Biosimilars Meeting Management Should Improve After Reorg In New Drug Office

Sep 11 2019

Generic Industry Wants US FDA To Consider Allowing Foreign Reference Products For ANDAs

Jun 29 2019

Biosimilar User Fee Collections Drop Well Below Estimates, But US FDA Not Worried

Jun 10 2019

Biosimilar Sponsors Want Off-The-Record Labeling Discussions With US FDA

Dec 10 2019

Two Months To Add Two Words – Biosimilar Supplement Review Times May Be Hindering Uptake

May 01 2019

AbbVie's 'Unjustified' Humira Settlements Divide Market, Class Action Claims

Mar 20 2019

BsUFA III: Industry Eyes Streamlined Review Of New Indications, Phased Review Process

Oct 22 2018

Make The ‘Purple Book’ More Orange, US FDA Told At Biosimilars Hearing

Sep 05 2018

US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs

Jun 07 2018

Related Companies

Amgen, Inc.

Additional Topics

United States User Fees Biosimilars Review Pathway Regulation Drug Review FDA Legislation BioPharmaceutical

More from User Fees

More from Pathways & Standards

Twitter feed RSS feed RSS feed

About Us

Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us

Customer Service
SubscribeOpens in new window
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.