Generics Bulletin 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


User Fee Bill Caught In Comey Firing Tidal Wave

Executive Summary

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

You may also be interested in...

User Fee Add-Ons: Senate Bill Tweaks Orphans, Opioids, Patient Data

Manager's amendment tells US FDA to issue more guidance for complex generics and tells GAO to report on progress towards global harmonization of data standards.

Senate's User Fee Bill Largely Steers Clear Of Controversy

HELP Committee manager’s amendment lacks provisions on such hot-button issues as off-label drug promotion, REMS abuses and right-to-try legislation.

Pediatric Study Timelines Could Change Under Senate PDUFA Bill

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.

Related Content


Latest Headlines
See All



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