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

FDA Staff ‘Literally’ Up At Night Deciding 3-Year Exclusivity Requests

Executive Summary

More sponsors are submitting applications around the same time requiring the agency to make complicated decisions about exclusivity and whether approval of subsequent applications is barred, FDA attorney says.

You may also be interested in...



Jazz Disputes FDA’s Approval Of Lumryz Over Xywav’s Orphan Exclusivity, Citing Lack Of Comparative Study

Lawsuit argues FDA wrongly determined that Avadel’s Lumryz is ‘clinically superior’ to Xywav because of once-nightly dosing. FDA’s Division of Neurology revised its initial opinion based on views of CDHR’s sleep team and additional input from the agency’s orphan drug office.

Senate Committee Passes Moderate PBM Reform, But Has Its Eyes On Stronger Policies

Delinking pharmacy benefits managers’ compensation from the prices of drugs received bipartisan rhetorical support at a HELP markup, but the panel only cleared less drastic PBM reforms along with generic and orphan-drug focused policies. Approved amendments tackled step therapy, pharma transparency and PBM gag clauses, among other topics.

EU Pharma Reform Proposes Cuts In Regulatory Protections & Faster Drug Approval Times

Proposals for the overhaul of the EU pharmaceutical legislation will make medicines more widely available, accessible and affordable while supporting innovation and boosting the “competitiveness and attractiveness” of Europe’s pharma industry, the European Commission claims. The research-based industry thinks otherwise, saying cuts in regulatory protections will undermine R&D.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148260

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