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 Implementer: How the Official Who Will Make FDAAA Work Views the New Law

This article was originally published in RPM Report

Executive Summary

The FDA Amendments Act transforms the drug safety system. In a recent address to the Food & Drug Law Institute, the acting head of the Center for Drug Evaluation & Research offered her view about what the law means and how the agency will make it work

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.

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS080206

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