Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Biosimilar User Fee Agreement Puts FDA On Hook For Delayed Guidances

Sep 22 2016

• By Sue Sutter

Related Content

FDA Sets New Goal For Biosimilar, Drug Promotion Guidances

Jan 22 2016

Biosimilar Interchangeability Requirements Pushed At <em>Inflectra</em> Review

Feb 15 2016

FDA's Biologics Naming Plan: Industry Wants 'Memorable' Suffixes

Nov 09 2015

BLAs More Appealing As 'Transition' NDAs, ANDAs Set To Lose Exclusivity

Mar 21 2016

Biosimilar Labeling: FDA Says Leave Comparability Data Out

Mar 31 2016

Biosimilar Non-Medical Switching: Advocacy Groups, FDA Advisors Push For Action

Jul 15 2016

FDA Biologic Transition Plan Creates 'Dead Zone' For Applications, Sponsors Fear

May 23 2016

Biosimilars' Pediatric Pressures Could Push Them Toward Interchangeability

Jul 15 2016

Biosimilar User Fee Agreement Offers FDA Funding Boost, Fee Structure Overhaul

Sep 17 2016

FDA Biosimilar Policy Continues To Evolve With Approval Of Sandoz Erelzi

Aug 31 2016

Biosimilar Labeling: Should FDA Just Throw Up Its Hands And Finalize Guidance?

Aug 05 2016

Related Companies

Novartis AG

Amgen, Inc.

Additional Topics

Review Pathway Regulation Biosimilars Drug Review BioPharmaceutical

More from Review Pathways

More from Pathways & Standards

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