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

Pediatric Study Timelines Could Change Under Senate PDUFA Bill

Executive Summary

Provisions aimed at earlier planning and completion of pediatric studies are part of user fee legislative package Senate committee will vote on May 10; measure also calls for FDA guidance on pediatric studies of molecularly targeted cancer drugs but does not require such trials.

You may also be interested in...



No Let Up In Downward Pressure On EU Drug Prices

Maarten Meulenbelt of law firm Sidley Austin explains the pricing challenges that face pharmaceutical companies in Europe during the remainder of 2022 and how they may have to adjust their strategies in order to succeed.

Off-Label Discussion, But No Additions, For House User Fee Bill

Several Republicans remain interested in expanding off-label communications, suggesting the issue could come up outside the user fee context, potentially as part of future drug pricing discussions.

User Fee Bill Caught In Comey Firing Tidal Wave

Senate committee forced to postpone mark-up of FDA user fee reauthorization legislation; drug pricing fight may be postponed by hearing pledge.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS120590

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