Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Unhappy With GDUFA II? Note It For GDUFA III, FDA Says

Nov 28 2017

• By Derrick Gingery

FDA entrance sign 2016

Related Content

Generic User Fees Need Small Business Waiver, Firms Say; Congress May Agree

Jun 24 2013

Complex ANDAs: Early Meetings With FDA Can Generate Bonus Communication

Oct 03 2017

GDUFA II: More Than 2,000 ANDAs Remain Unclaimed, Large Firms Still Dominate

Apr 17 2017

New ANDA Review Pathways: Should You Be A Priority Or Expedited?

Nov 13 2017

FDA Considers Providing Mid-Review Update For First Generics

Sep 18 2014

Complex ANDAs To Be Allowed Pre-Submission Product Meetings

Oct 24 2016

PDUFA VII Already: Could Breakthrough Ideas Apply Outside Program?

Aug 26 2016

Related Companies

Viatris Inc.

Apotex Inc.

Additional Topics

United States Generic Drugs Review Pathway Regulation FDA BioPharmaceutical

More from Generics

More from Biosimilars & Generics

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