Pink Sheet is part of the Business Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

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.'

Advertisement

Related Content

ANDA Stress Test: End-Of-Year Submission Bolus Pressures US FDA Review System
ANDA Withdrawals Increase Faster Than Approvals
Generic User Fee Renewal Talks Faced 'Buyer's Remorse' From GDUFA I
Generic Drug First-Cycle Approval Rates Lagging Under GDUFA I
ANDA Approvals, Complete Responses Hit Record In FY 2016
FDA Meets ANDA Backlog Goal Early, Still Doesn't Feel Out Of Woods
Drug Pricing Panacea Or Just PR Victory? Expedited ANDAs May Have Limited Impact

Topics

Advertisement
UsernamePublicRestriction

Register

PS119418

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

Cancel