Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

How US FDA's Assumptions Impacted Generic Program Fees

Executive Summary

FDA decided against trying to predict upcoming approvals as part of FY 2019 GDUFA program fee calculations, but other adjustments likely increased fee significantly.

You may also be interested in...



FDA Obscura: GDUFA Fee Calculations Took CBER-Regulated ANDAs Into Account

ANDAs regulated by the US FDA's biologics center, some pre-1984 conditional approvals, and others were factored into GDUFA program fee calculations.

Generics Firms Race To Withdraw ANDAs

Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.

Generic Companies Race To Withdraw ANDAs

Industry consolidation may be a reason ANDA withdrawals have increased during GDUFA II.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS123587

Ask The Analyst

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

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

Cancel