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


Generic Exclusivity? Who Cares! Industry Offers Few Opinions On Potential Changes

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA officials still looking for input after transparency issue not widely addressed during GDUFA policy meeting.

You may also be interested in...

FDA’s Patent And Exclusivity Team Aims To Ensure Timely First Generics

Generic drugs office will proactively seek litigation and other information that could affect launch timing.

‘First Generic’ Definition Is Two-Sentence Tug Of War For FDA, Industry

FDA offers two-prong criteria to determine which ANDAs would get priority in review system; industry wants expanded classification that includes drug shortages.

ANDA Expedited Review Criteria MaPPed Out By FDA Generic Drug Office

CDER staff manual outlines seven categories of submissions that can qualify for expedited review, including some ANDAs with patent certifications and supplements that have the potential to create an “extraordinary hardship” for a sponsor if not addressed quickly.

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