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

New Risk Management Landscape For Drugs Offers Fertile Ground For CROs

Executive Summary

The coming year could see the first use of the enhanced safety powers created by the FDA Amendments Act, but 2008 is certain to see a shift in the pharmaceutical industry's development approach as it grapples with the need for more safety data

You may also be interested in...



FDA Hires Consultants To Ease Conflicts Between CDER Staff

FDA is bringing in outside consultants to help improve staff interactions and build leadership in the agency's Center for Drug Evaluation and Research

FDA Bill Passes; Congress Adds $225 Million To Industry User Fee Burden

Final FDA reform legislation that cleared Congress adds an additional $225 million to industry's user fee tab over five years, but limits penalties that FDA can assess to enforce its new authorities to mandate labeling changes and postmarket studies

Phase IV Commitments Are Increasingly Delayed, FDA Report Finds

The rate of delayed postmarketing commitments has increased since 2005, according to data provided in FDA's annual "Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies.

Latest News
UsernamePublicRestriction

Register

PS049158

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