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

Rx Safety Bill Would Require Renegotiation Of User Fees, FDA Tells Senate

Executive Summary

An expansion of FDA's drug safety authorities as envisioned by legislation from Sens. Ted Kennedy, D-Mass., and Michael Enzi, R-Wyo., would require a renegotiation of user fees with industry, Commissioner Andrew von Eschenbach said

You may also be interested in...



PDUFA Draft Bill Adds $70 Mil. For Rx Safety To User Fee Totals; Mark-Up Looms

A draft of the bill to reauthorize FDA's user fee program would add $70 million to the total fee negotiated by the agency and industry in order to pay for additional Rx safety oversight

PDUFA Draft Bill Adds $70 Mil. For Rx Safety To User Fee Totals; Mark-Up Looms

A draft of the bill to reauthorize FDA's user fee program would add $70 million to the total fee negotiated by the agency and industry in order to pay for additional Rx safety oversight

Will Zelnorm Tip The Scales To Increased Drug Safety Oversight Thru PDUFA?

Novartis' suspension of marketing of Zelnorm could add momentum to efforts to attach drug safety reform language to the Prescription Drug User Fee Act reauthorization legislation

Related Content

Latest News
See All
UsernamePublicRestriction

Register

PS048161

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