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

UsernamePublicRestriction
UsernamePublicRestriction

CERTs Look to Re-Assert Larger Role in Post-Marketing Surveillance

This article was originally published in RPM Report

Executive Summary

There is growing pressure on FDA and Congress to create public-private partnerships for enhanced postmarketing surveillance. The Agency for Healthcare Research and Quality already runs an existing network of academic centers that could fit the bill nicely.

You may also be interested in...



Building the Right Foundation: An Interview with Mark McClellan

The Reagan-Udall Foundation is an early priority for FDA in implementing the landmark legislation enacted by Congress in 2007. It is also a lightning road for criticism from Congress about the agency's relationship with regulated industry. We asked foundation chairman Mark McClellan for a status report.

FDA's Drug Safety Changes: Safe Legislation; Unsafe Climate

The message from RPM's FDA/CMS Summit Conference: if you want to handicap the effect of the continuing drug safety debate around FDA, you can track the progress of the Kennedy-Enzi bill through Congress - and listen to the tone of the comments from the agency's top managers and its critics. Both will tell you what's at stake for pharma in 2007.

Drug Safety Reform: Did FDA Buy Time or Trouble?

FDA's senior management is worried that it may have created a political Frankenstein when it called for an outside review of the agency's role in drug safety decisions by the Institute of Medicine. The agency asked for the study to take the heat out of Congressional efforts to split up safety and efficacy reviews. The committee has shown interest in the arguments to create new publicly-funded centers for post-market trials.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1135415

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