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

User Fee Package Offers FDA Reforms From A House Wary Of FDA Power

Executive Summary

House drafters’ dissatisfaction with FDA’s performance is evident in several provisions of draft user fee legislation. The agency would be required to finalize some guidances within a year of issuing a draft, which likely would provide more predictability for industry.

You may also be interested in...



Did PDUFA V Pass Too Quickly?

The pending Supreme Court decision on the Affordable Care Act may have forced negotiators to finish quicker than they would have liked as legislators indicate some more time may have produced an agreement on track-and-trace standards; stakeholders may question whether the bill could have been improved had the deadline not been looming.

User Fee Conference Committee Targets Settling Differences In June

A conference committee tackles differences between House and Senate FDA user fee and agency reform bills, with an agreement expected before the end of June.

User Fee Conference Committee Targets Settling Differences In June

A conference committee tackles differences between House and Senate FDA user fee and agency reform bills, with an agreement expected before the end of June.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS054284

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