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

GDUFA: Review Costs Continued To Climb Once Formal Review Goals Began

Executive Summary

Generic drug reviews during the first year of formal review goals cost 70% more than during GDUFA's inaugural year.

You may also be interested in...



ANDA Approvals, Submissions Decline With New Review Goal Coming

Is a rush of generic applications seeking the 10-month clock on the way?

Woodcock's Legacy: CDER Organizational Improvements

In interview with the Pink Sheet, Center for Drug Evaluation and Research director discusses her 30-year career, retirement speculation, and upcoming projects.

Generic User Fee Talks Reach 'Final Wording' But Still Not Done

FDA and industry say they have reached tentative agreement, but finance subgroup says more discussion needed.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119024

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