HBW Insight 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

Conflict Of Interest Rules Removed In Draft Of House User Fee Bill

This article was originally published in The Tan Sheet

Executive Summary

Reforms would end waiver caps for conflicts of interest, but whether they will solve the problems patient groups and others have with the advisory committee selection process is unclear. In a discussion draft, FDA could issue as many waivers of financial conflicts as it chose.

You may also be interested in...



Battle Lines Clear On Conflict Of Interest Policy In PDUFA Reauthorization

Commissioner Hamburg says the agency likely does not need legislation to improve its conflict of interest policy, but House members still say the system needs reform. Industry and patient advocate groups push for change, while consumer groups press FDA to stand firm.

Conflict Of Interest Reform: With FDA Undecided, Consumer Groups Give Their Pitch

FDA likes some rules in FDAAA and wants to continue discussion with Capitol Hill as changes are expected to be part of PDUFA legislation.

PDUFA Word Association: Consumer Advocates Complain About Lack Of "Safety" In Commitment Letter

FDA’s Oct. 24 public meeting on the renewal of its drug user fee program demonstrated just how strong a position the agency is in regarding the renewal of the Rx part of the “UFA” legislation – most of the complaints were semantic, quite literally.

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

RS124746

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