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


The Opening Volley in the Drug Safety Debate

This article was originally published in RPM Report

You may also be interested in...

FDAAA Impact Analysis: Year One

The RPM Report’s analysis of the fi rst year under FDA’s new law makes one fact clear: sponsors seeking approval for never-before-marketed ingredients need to assume the new tools will apply to them.

Rethinking Phase IV: Congress Wants to Get Tough on Post-Marketing Requirements, but FDA May Soften the Blow

Congress is ready to grant FDA more authority over Phase IV studies-over the objections of both agency officials and drug sponsors. But if FDA is right, improvements to the designs of post-marketing studies may help reduce the impact on industry.

Time to Pay the Piper? Industry Prepares for a Fight Over User Fees

The pharmaceutical industry and FDA are getting ready for a fight-and for once they are on the same side. They want Congress to reauthorize the Prescription Drug User Fee Act quickly and cleanly-without tacking on other reforms to FDA's drug regulations. They probably won't get their wish.

Related Content


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