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

Are 180-Day Exclusivity Changes Moving Out Of Drug Pricing Plans?

Executive Summary

US FDA softens its tone on idea and encourages industry to voice its (predominantly negative) opinion publicly.

You may also be interested in...



Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances

FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.

Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances

FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.

180-Day Exclusivity Changes Pushed In Biden’s Budget Proposal

The legislative proposal would make first-filer exclusivity function similar to the competitive generic therapy program, allowing additional approvals if the commercial launch is delayed.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS123064

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