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

UsernamePublicRestriction

FTC 'Ready' To Go After Abusive Citizen Petitions; Allergan Wants 'Substantive' FDA Responses

Executive Summary

US FDA draft guidance on citizen petitions elicits comments of support, including call to exclude brand manufacturer petitions except in urgent situations.

You may also be interested in...



FDA Guidance Tackles Citizen Petition 'Shenanigans'

Final guidance published by the US FDA on citizen petitions seeks to put an end to the originator ‘shenanigans’ of using petitions to delay competition.

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New draft guidance says citizen petition abuses will be referred to FTC and publicly called out as attempts to delay ANDA approvals.

Shire's Citizen Petitions Too Old For FTC Action; Door Left Open For Amended Suit

 Court tosses FTC complaint alleging Shire used the citizen petition process to maintain a monopoly on Vancocin, says agency did not show company was 'about to violate' the law.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB002462

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