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 Negotiations: Contract Manufacturers Gain Seat At Table

Executive Summary

Generic user fees could be segmented further by addition of new group.

Advertisement

Related Content

Generic User Fee Renewal Talks Faced 'Buyer's Remorse' From GDUFA I
GDUFA II: FDA Prefers A ‘Manageable Number of High-Impact Changes’
Generic User Fees: FDA Goes On Backlog Offensive
ANDA Approval Improvements Reveal Just How Big The Backlog Is
ANDA Renaissance: FDA Aims To Reduce Refuse-To-Receive Actions
FDA Generic Office Director Uhl Returns From Medical Leave
Biosimilar User Fee Negotiations Won't Start Until 2016
GDUFA Stakeholder Deadline May Come After Negotiations Conclude
GDUFA Stakeholder Deadline Extended; Are Talks Delayed?
GDUFA Talks: FDA Reminds Industry The Program Is Generic-Only

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register