In Vivo 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


U.S. Generic Exclusivity Process To Go Public?

This article was originally published in PharmAsia News

Executive Summary

The U.S. FDA wants to know whether its 180-day generic exclusivity process should be revealed up front; the question will be one of many on ANDA reviews to be considered at a September public hearing.


Related Content

ANDA Expedited Review Criteria MaPPed Out By FDA Generic Drug Office
FDA Generics Office Finalizing Structure As Review Goals Approach
ANDA Avalanche: How Will FDA Deal With The 600 Received This Month?
Generic Drugs 2014: OGD Creates Internal Review Goals, May Make OND-Inspired Changes
FDA Will Allow ANDA Corrections … Until 10 Minor Deficiencies Found
FDA First-Generic Notification Policy May Be Reviewed





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