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


Conflict Of Interest Rules Get Clean Sweep In House Draft User Fee Bill

Executive Summary

Reforms merit one sentence, which would end waiver caps for conflicts of interest, but it is unclear whether it will solve the problems patient groups and others have with the advisory committee selection process.

You may also be interested in...

Conflict of Interest Reform: Greatest Impact May Be Committee Vacancy Rate

FDA user fee reauthorization eliminates limits on waivers, which may ease the burden on FDA to fill open seats on its advisory committees. Vacancy rates have been as high as 24% in FY 2012.

PDUFA Scrubbing: How The House User Fee Bill Got So Agreeably Clean

Profound reforms to FDA’s mission were set aside, but industry seems poised for several big wins, including (probably) additional antibiotic exclusivity and even a national track and trace standard.

Senate User Fee Bill Heads To Mark-up Without Track-And-Trace

Manager’s amendment released in lead-up to committee mark-up still does not include drug tracking provisions, but will expand advisory committee recruiting and eliminate conflict of interest waivers using language in Rep. Burgess’ bill.

Related Content


Related Companies

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