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


GDUFA II Negotiations: Let the Saber-Rattling Begin

This article was originally published in RPM Report

Executive Summary

The reauthorization of the Generic Drug User Fee Act isn’t going to be as straightforward as the PDUFA process has been for the past two decades. Instead, expect a replay of the first medical device fee renegotiation – with plenty of threats from industry to walk away from the program altogether, likely intended to end up with the best possible deal.

You may also be interested in...

Fixing Drug Pricing? Congress Enacts Generic Inflation Rebate And Turns Up Heat On FDA

Amid a storm of controversy about “re-pricing” of older brands, the US Congress has reacted in two seemingly contradictory ways. First, new legislation creates what amounts to a tax on generic drug companies who raise prices. At the same time, legislators are eager to press FDA to move faster on generic drug approvals to assure competition for high priced brands.

Generic Drug Sponsors Will Get Status Reports – But Only For Old ANDAs

FDA is ready to restore some informal communications for generic drugs, but only for applications not covered by the newly implemented user fee action dates.

FDA Generics Office To Be Managed By Relative Unknown

Director Uhl’s medical leave puts bioequivalence office head John Peters in the limelight.

Related Content


Related Companies

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