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.