Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

PDUFA V: FDA Relaxes Pre-Submission Meeting Requirement

Mar 28 2011

• By Derrick Gingery

Related Content

FDA Floats 15-Month Review Timeline For PDUFA V; Firms Mull Tradeoff On Speed Vs. Certainty

Dec 13 2010

PDUFA V: FDA Application Completeness Crackdown Continues

Feb 07 2011

User Fee Waivers For Small Businesses Might Get Smaller Under PDUFA V

Mar 14 2011

FDA Wants To Lengthen Review Time For Some Prior Approval Supplements

Mar 28 2011

FDA Could Answer "Clarifying" Questions, But Only For Firms Without Approved Product

Feb 28 2011

FDA May Require NDA Pre-Filing Meeting Under PDUFA V Review Model; Pilot Launching Soon

Feb 28 2011

Additional Topics

BioPharmaceutical

More from Archive

More from Pink Sheet

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