Pink Sheet is part 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 User Fee Proposal From Industry Relies Heavily On Establishment Fees

This article was originally published in The Pink Sheet Daily

Executive Summary

The plan would require 80% of generic drug user fee revenue to come from finished dosage manufacturers and 20% from API manufacturers.

You may also be interested in...

Drug Shortage Prevention Could Be Funded Through GDUFA

GPhA recommends FDA deploy user fee research money to look at shortage risk assessment and mitigation strategies, while the trade group continues to look for a product to fit its own shortage prediction model.

Regulatory Science Next To Be Outsourced?

CDER report calls for broader partnerships with outside bodies in regulatory science.

Generic User Fee Talks: Performance Metrics For Early Years Still Unresolved

Industry and FDA appear largely in agreement on goals for the generic drug user fee program after it gets off the ground, but are stuck on how to determine agency performance in its early years.

Related Content





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