Generics Bulletin 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


Assessment Times Improve Under GDUFA

Executive Summary

Averages likely will increase as more of the cohort is approved, however.

You may also be interested in...

US FDA Begins Building Pharma Industry Activity Prediction Tool

Algorithms are intended to help predict incoming workload, which will be used to help set user fees.

US FDA First-Cycle ANDA Approvals Not Rising Along With Full Clearances

While FDA is on pace to again break its record for full ANDA approvals in FY 2019, the first-cycle approval rate is dropping, as illustrated in our charts.

Rounding Up And Down: Assessing FDA FY 2019 and FY 2020 Workload Estimates

US FDA provides a few hints about upcoming industry application filing volume and the agency's assessment pace in FY 2020 budget documents.

Related Content


Latest Headlines
See All



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