Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


FDA Product Promotion Regs Shouldn’t Stop Companies From Challenging CER Results, Official Says

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Bob Temple dismisses the notion that drug companies, even with FDA’s regulation of product promotions, do not have the ability to challenge comparative effectiveness research findings they believe to be false or misleading. He says FDA is in no way trying to “deny them that right.”

You may also be interested in...

Will FDA’s View On Health Economic Claims Change With More Government-Funded Research?

Health care economic information that is disseminated to formulary committees must be based on “competent and reliable scientific evidence.” Yet FDA has traditionally applied a more restrictive “substantial evidence” standard in its enforcement approach, said panelists at a recent conference, who questioned whether the growing government involvement in funding comparative effectiveness research would change this approach.

Equal Access To Data Needed For CER To Be Effective, NPC Exec Says

With the Patient-Centered Outcomes Research Institute beginning the early grant process and other data collection initiatives such as FDA’s Sentinel and Janus programs also underway, National Pharmaceutical Council Chief Science Officer Robert Dubois is recommending changes in policy that will allow equal access for industry and academia to data used in comparative effectiveness studies.

FDA 2015 Budget Increase Proposal Leans On Food Safety User Fees

Food safety programs would get the largest increase in the White House’s proposed fiscal 2015 FDA budget, and increases in user fee programs are proposed as key drivers for the boost. The agency’s overall budget would grow $335 million to $4.7 billion in the proposal.


Related Companies




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