Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Personalized Medicine Will Require Greater CDER, CDRH Cooperation

Executive Summary

Drug regulation during an era of personalized medicine will require cultural if not structural changes on the part of FDA

You may also be interested in...



“Critical Path” Is On The Road Forward; FDA Reports Industry Activity Is High

The Critical Path Initiative is entering 2007 with growing momentum, bolstered by a new, tailored agency infrastructure and increased industry awareness of FDA's initiative to spur drug development

NDAs Should Include More Cross-Study Analysis, FDA Says In Draft Guidance

FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications

New Look At Ezetimibe Fails To Confirm Vytorin Cancer Signal

Interim data from SHARP and IMPROVE-IT trials fail to show evidence of impact on cancer rates.

Latest News
See All
UsernamePublicRestriction

Register

PS048824

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