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: Inspection Information Takes Center Stage

This article was originally published in The Pink Sheet Daily

Executive Summary

Sponsors say transparency is important as generic drug user fee negotiations move to inspection policy.


Related Content

US FDA's Inspection Decisions To Be Swayed By Facility "History" With Foreign Regulators
FDA Will Soon Begin Alerting Generics Firms To Facility Compliance Status
FDA Inspections Ombudsman Could Help Foreign Manufacturers
FDA Inspections Ombudsman Could Help Foreign Manufacturers
Review Times Remain A GDUFA II Topic
In Brief: GDUFA inspections, FDA’s inspection workforce, device warning letters, 3D drug printers, CMC/GMP guidance agenda
Energy And Commerce Members Want FDA Overseas Operations Update
Risk-Based Inspections Might Actually Be Hurting Compliant Firms
GDUFA: How Much Does FDA Know About U.S. Generic Market After Facility Self-Identification?
Establishment Fees Protect American Manufacturing, Mylan Argues In User Fee Proposal





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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

Ask your question to our analysts