Pink Sheet is part of the Informa 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 Launch Pains: Facility List Fluctuations, Back-Due Backlog Fees

Executive Summary

FDA still has backlog fees in arrears more than two months past the payment deadline, but cannot forcibly withdraw the applications; facility listings also change consistently because industry can update them as needed.


Related Content

GDUFA: Fee Avoidance Affects Rates Again
GDUFA: FDA Sees High Fee Collection Rate After First Six Months
Growing Pains for Generic Drugs: OGD Gains Respect, But Loses Geba
ANDA Backlog Withdrawals May Stimulate Secondary Market By Foreign Firms
GDUFA Self-Identification Woes Can’t Deflate Industry, FDA Enthusiasm
Backlog Backfire: FDA Sees Increase In Pending Generic Applications At Deadline
ANDA User Fees: Negotiators Close To Agreement, But Backlog Is Sticking Point





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