Abstract
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.
| 
View Cart
