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

ANDA Holder Fee Will Start With Industry-Driven Database 'Clean-Up'

Executive Summary

FDA is again relying on sponsor self-reporting as it launches GDUFA II.

Advertisement

Related Content

GDUFA II: More Than 2,000 ANDAs Remain Unclaimed, Large Firms Still Dominate
Generic Industry Consolidation Illustrated In ANDA Holder List
GDUFA II: Industry Shares Stage With FDA
User Fees For FY 2017 Make Sponsors Happy, Manufacturers Sad
GDUFA: Will Industry Self-Identification Push Lengthen The Backlog?

Topics

Advertisement
UsernamePublicRestriction

Register

PS119379

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

All set! This Question has been sent to my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Add a personalized Question to your Analyst

Cancel