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

The Risk of Risk Management

This article was originally published in RPM Report

Executive Summary

Risk management plans are an increasingly common feature of new drug approvals, and Congress seems set on making them a standard part of the FDA review process. Industry seems willing to go along, accepting some more restricitions on new products in exchange for restoring confidence in drug safety. There is only one problem: FDA is not so sure this is a great idea.

You may also be interested in...



Waking Up to REMS (Part 1): Don't Believe the Lack of Hype

FDA's top management can't be accused of overstating the importance of the agency's new drug safety tools. But sponsors need to wake up to the reality: the REMS are a critical fact of drug development and marketing.

FDA and Health Care Reform: An Activist Agenda for the Agency

Everyone is gearing up for a debate over health care reform in 2009-including the Food & Drug Administration. The regulator's role may be bigger than you think.

FDA and Health Care Reform: An Activist Agenda for the Agency

Everyone is gearing up for a debate over health care reform in 2009-including the Food & Drug Administration. The regulator's role may be bigger than you think.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS080178

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