Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

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.

You may also be interested in...



GDUFA II: Priority Reviews Considered For Some ANDAs

New pathway could restart argument between industry and FDA over what qualifies for expedited review.

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.

FDA/Generic Communications Plan Restoring Best Of Past Practices

Office of Generic Drugs wants to allow project managers to inform sponsors of major deficiencies before ‘complete response’ letter as part of ‘go/no go’ effort.

Related Content

Topics

UsernamePublicRestriction

Register

PS056319

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

Cancel