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

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

This article was originally published in RPM Report

Executive Summary

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.

You may also be interested in...



Merck's Cordaptive: Just Another Cholesterol Combo, or More?

At first glance, Merck's Cordaptive is yet another combination drug for cholesterol. But by unlocking the significant medical benefits of niacin, the treatment may represent an important advance. Cordaptive contains an anti-flushing agent which reduces the key side-effect preventing wider niacin use.

Merck's Cordaptive: Just Another Cholesterol Combo, or More?

At first glance, Merck's Cordaptive is yet another combination drug for cholesterol. But by unlocking the significant medical benefits of niacin, the treatment may represent an important advance. Cordaptive contains an anti-flushing agent which reduces the key side-effect preventing wider niacin use.

A New Phase for Phase IV: Post-marketing Studies Won't Be the Same After Drug Safety Bill

The world of post-approval research is going to get more public, more crowded, and more dangerous to pharma. Post-marketing surveillance, transparent clinical trial results and mandated post-approval studies mean the traditional world of marketing-oriented Phase IV is about to change dramatically.

Related Content

Topics

UsernamePublicRestriction

Register

PS080274

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