Generics Bulletin 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


FDA Aims To 'Pierce The Rhetoric' On Generic Application Backlog

Executive Summary

ANDA backlog is now largely cleared, FDA's Uhl notes, 'and in many cases we've actually gone above and beyond our negotiated commitments in order to really meet the stakeholder expectations.'

You may also be interested in...

Generic User Fee Renewal Talks Faced 'Buyer's Remorse' From GDUFA I

Industry dismay at slow pace of ANDA approvals and FDA communications in early years of first user fee agreement factored into GDUFA II negotiations.

Generic Drug First-Cycle Approval Rates Lagging Under GDUFA I

Only 8% of original ANDAs submitted in the user fee program’s third year were approved on the first cycle, compared with 72% that received a complete response letter.

ANDA Approvals, Complete Responses Hit Record In FY 2016

FDA's Office of Generic Drugs completes its best year of the GDUFA era.

Related Content





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