Biotechnology, Pharmaceutical and Life Science Reports and Courses

Main Pages

Best Selling Products

BioNewsCast Press Release Distribution Service

Bioinformatics Market Potential

Vaccine Research & Development 2009

Veterinary Diagnostics Markets

Practical Guide to Finding Partners in Pharma & Biotech, 2nd edition

New Products

Advanced Wound Management Pipeline Technology and Market Forecasts to 2015

Artificial Disc Replacement Pipeline Technology and Market Forecasts to 2015

Brazil Anesthesia and Respiratory Devices Market Analysis and Forecasts to 2015

Brazil Orthopedic Devices Market Analysis and Forecasts to 2015

Canada Anesthesia and Respiratory Devices Market Analysis and Forecasts to 2015

Canada Diabetes Care Devices Market Analysis and Forecasts to 2015

Canada Medical Equipment Market Analysis and Forecasts to 2015

Cardiac Assist Devices Pipeline Technology and Market Forecasts to 2015

China Medical Equipment Market Analysis and Forecasts to 2015

Chronic Diseases on the Rise: Personal Health Systems to Play a Key Role in Disease Management

BioPortfolio | Business Insights | Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and industry response

Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and industry response

Drug safety has become a major industry concern following the market withdrawal of Merck’s Vioxx in 2004 and several other discontinuations of COX-2 inhibitors. Although adverse reactions were previously considered a relatively minor risk compared to a drug’s wider benefit, both newly approved and established drugs are now under intense scrutiny. Drug approvals in the US and Europe have become subject to approval delays, rising requests for further clinical data, and greater chances of rejection. Regulators are currently attempting to reconfigure review processes in order to minimize delays in recognition of the potential mass benefits of new applications Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and industry response is a new report published by Business Insights that provides a comprehensive review of current drug approval trends in the US and Europe with case studies highlighting successful and unsuccessful applications. Emerging regulatory developments and process improvements are examined and the strategic measures implemented by developers to enhance the approval potential of their drugs are assessed. This report also evaluates the future regulatory landscapes of the FDA and EMEA, with a review of anticipated developments through to 2012. Understand the changing landscape for FDA and EMEA drug approvals, discover the implications of process overhauls upon your drug applications and anticipate future regulatory developments with this new report.

Published: April 2008 - Global.
Table of Contents
Price: $3,835.00 / €2,563.31

BioPortfolio uses RBS Worldpay Secure Server for credit card transactions