Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

GDUFA II Will Include Small Business Relief, Priority ANDA Reviews

Executive Summary

Generics industry and FDA have resolved remaining issues regarding financing of user fee program.


Related Content

Califf Optimistic As He Departs US FDA
Mylan's EpiPen Nightmare Not Over Yet, But Will Congress Just Write?
EpiPen Outrage In Congress Puts Spotlight On FDA Generic Review
You Just Have To Wait: FDA Can't Hurry PDUFA VI Guidances
ANDA Approvals, Submissions Decline With New Review Goal Coming
GDUFA Negotiations Shift To 'Tiered' Fee Models
Two Out Of Three Ain't Bad: Biosimilar User Fee Talks Completed
Drug Pricing Panacea Or Just PR Victory? Expedited ANDAs May Have Limited Impact
Pre-ANDA Meeting Goals May Be Created In GDUFA II
GDUFA II: Facility Fees Might Be Deferred Until ANDA Approval


Related Companies