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


ANDA Expedited Review Criteria MaPPed Out By FDA Generic Drug Office

Executive Summary

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

GDUFA II: Priority Reviews Considered For Some ANDAs
FDA’s Patent And Exclusivity Team Aims To Ensure Timely First Generics
FDA/Generic Communications Plan Restoring Best Of Past Practices
FDA/Generic Communications Plan Restoring Best Of Past Practices
‘First Generic’ Definition Is Two-Sentence Tug Of War For FDA, Industry
Generic Exclusivity? Who Cares! Industry Offers Few Opinions On Potential Changes
New Generics Team Will Improve Review Efficiency, Consistency
U.S. Generic Exclusivity Process To Go Public?
Pharmaceutical Quality And Generic Drugs: Janet Woodcock Explains Her Vision
“First Generics” Will Get Expedited ANDA Reviews Under New FDA Policy





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