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

Congress’ Next Steps On REMS Abuses: Will Improving FDA-FTC Communication Help?

Executive Summary

US FDA has seen little success in ending gaming of the patent process by brand name manufacturers. One problem: the agency’s referrals to FTC on anti-competitive cases appear go into a black box.

You may also be interested in...



REMS Abuse Website: Celgene, Actelion Top List Of Suspected 'Gamers'

Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.

REMS Abuses: Congressional Panel’s Focus Turns To Federal Trade Commission

During bipartisan, but one-sided, hearing about US FDA’s limited authority to ensure generic drug makers can access restricted distribution reference products for bioequivalence testing, one lawmaker wants to know what FTC is doing about the issue.

NDAs, BLAs To Start Getting KASA Quality Risk Assessments After Successful Pilot With ANDAs

Internal review system reduces US FDA’s administrative work for OPQ risk assessments; agency’s standards will not change, and sponsors will not need to modify applications. Advisory committee endorses expansion, which will roll out to different application types over several years.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS125508

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