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

AAM, PhRMA Renew Rivalry In Hatch-Waxman Public Comments

Executive Summary

Generic association advocates enforcement action against companies that use REMS to block generics while PhRMA disputes claims of REMS abuse and citizen petition delay tactics.

You may also be interested in...



REMS Abuse Website: Has It Changed The Behavior Of Innovators?

Updated numbers from the US FDA's REMS abuse website show that Celgene has received two additional safety determination letters, raising question's about whether the public list has changed the practices of brand companies hindering generic company access to samples.

Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers

New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.

Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers

New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS122010

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