Generics Bulletin is part 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 Sponsors Get Wide-Open Facility Deadline For Priority Review

Executive Summary

User fee legislation says facility information to qualify for priority review must arrive two months in advance of ANDA, conflicting with narrow 'window' in FDA's draft guidance.

You may also be interested in...

FDARA Takes Effect With Under-The-Radar Presidential Signature

Key FDA legislation moves to implementation phase with presidential signature but little fanfare.

Implementing User Fees Should Be Lighter Lift For FDA This Time Around; Bill Heads To White House

The 2017 user fee reauthorization bill contains provisions that should be significantly easier for the agency to implement compared with the 2012 measure. Senate clears clean bill for president's review.

FDA Offers To Expedite 'Priority' ANDA Reviews By Previewing Facility Information

An FDA guidance lists the criteria for reviewing “pre-submission facility correspondence” that permits expedited approval of priority generic drugs by allowing facility information to be reviewed prior to the submission of an ANDA. This mechanism was established by GDUFA II.

Related Content


Related Companies




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