Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

US FDA's Biosimilars Chief Leah Christl Plans Departure

Jan 11 2019

• By Derrick Gingery and Sue Sutter

FDA entrance sign 2016

Related Content

Celltrion’s Rituximab Biosimilar Has Easy US FDA Panel Ride Despite Questions About Narrow Label

Oct 10 2018

US FDA's Biosimilar Advisory Committee Policy Evolves

Jul 09 2018

Suffix Smackdown: Gottlieb Calls Issue 'Red Herring' For Biosimilars

Jul 19 2018

US FDA Appoints Another Orphan Products Development Office Head Amid Growth Expectations

Oct 15 2018

Jenkins’ Exit Interview: He’ll Miss Insider Status Upon FDA Departure

Dec 13 2016

Should A Biosimilar Sponsor Do The 'Patent Dance?' It Depends On Many Things

Aug 22 2017

Two Out Of Three Ain't Bad: Biosimilar User Fee Talks Completed

Jun 20 2016

Office Of New Drugs Reorg Is Bigger Than Expected: US FDA Adds 11 Review Divisions

Jun 04 2018

CDER Recruitment Wins Begin Outnumbering Losses

Nov 27 2018

Peter Stein Takes Short Path To Director Of US FDA Drug Office

Dec 10 2018

Best Of Biosimilar Agreement: FDA, Industry Tout Written Response, Pre-Submission Meeting

Jun 29 2017

US FDA Taps Abernethy As Principal Deputy Commissioner; Health IT Exec Brings “Real-World” Expertise

Dec 17 2018

With Biosimilar Statistical Guidance Withdrawn, Expect Sponsor-Specific Advice, FDA's Christl Says

Jun 26 2018

Biosimilar Advisory Committee Reviews: Necessity Or Nuisance?

Jul 20 2016

Related Companies

Celltrion, Inc.

Novartis AG

Amgen, Inc.

Pfizer Inc.

Viatris Inc.

Biocon, Ltd.

Roche Holding AG

Additional Topics

United States Biosimilars FDA Regulation Leadership BioPharmaceutical

More from Biosimilars

More from Biosimilars & Generics

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