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

UsernamePublicRestriction

Citizen Petitions Targeting ANDAs Recede, But Concerns Over Resources Remain

Executive Summary

FDA worries about diverting resources to respond to 505(q) petitions, despite receiving lowest number in fiscal year 2015 since it began tracking requests.

You may also be interested in...



US FDA Changing View Of Citizen Petition Response Time, Could Eliminate Serial Refiling

By aligning petition filing deadlines with user fee goals, agency could discourage petitions that need response within 150 days, potentially ending non-substantive response practice.

US FDA Changing View Of Citizen Petition Response Time, Could Eliminate Serial Refiling

By aligning petition filing deadlines with user fee goals, agency could discourage petitions that need response within 150 days, potentially ending non-substantive response practice.

US FDA Amps Up "Name And Shame" Approach To Thwart Anti-Generic Tactics

New draft guidance says citizen petition abuses will be referred to FTC and publicly called out as attempts to delay ANDA approvals.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS118999

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