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Crystallize Your Business Decisions With Drug Approval Trends at the FDA and EMEA Report

Posted on: Tuesday, 13 May 2008, 09:01 CDT

Research and Markets (http://www.researchandmarkets.com/reports/c91636) has announced the addition of "Drug Approval Trends at the FDA and EMEA: Process Improvements, Heightened Scrutiny And Industry Response" to their offering.

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

Business Intelligence for the Pharmaceutical Industry

The portfolio of healthcare management reports is designed to help you make well informed and timely business decisions. We understand the problems facing today's pharmaceutical and healthcare executives when trying to drive your business forward, and appreciate the importance of accurate, up-to-date, incisive product, market and company analysis. We help you to crystallize your business decisions.

The strength of our research and analysis is derived from access to unparalleled databases and libraries of information and the use of proprietary analytic techniques. Business Insights reports are authored by independent experts and contain findings garnered from dedicated primary research. Our authors' leading positions secure them access to interview key executives and to establish which issues will be of greatest strategic significance for the industry.

Our healthcare portfolio of reports can be used across a wide range of business functions to assess market conditions and devise future strategy. Our reports cover key areas including strategy, industry analysis, market outlook, new business opportunities and strategic insight.

Some key findings from this report...

- The FDA and EMEA are asking for more data in drug applications that pose heightened safety concerns, although there have been no official changes in overall drug approval standards.

- The number of new molecular entities approved in the US each year has declined from 36 to 18 since 2004, despite a sustained increase in the amount of clinical trials conducted.

- The EMEA is approving fewer products than the FDA even though processing speed and volume have been significantly improved. System reforms include reduced review times, faster approvals for innovative drugs and relaxed requirements in pediatric trials.

- Information about new drug candidates is being increasingly shared by the FDA and EMEA as globalization continues throughout the pharma industry. Such convergence is prominent in the orphan drugs area, where evaluations require considerable resources.

- Biosimilar approval structures in the EMEA are significantly more comprehensive than those of the FDA. Europe is now becoming the global center for biosimilar development and production.

Drug Approval Trends at the FDA and EMEA

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 benefit 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 changes upon your drug applications and anticipate future regulatory developments with this new report...

Contents:

Chapter 1 The shifting regulatory landscape

Chapter 2 Drug approval trends at the FDA

Chapter 3 Drug approval trends at the EMEA

Chapter 4 Industry response

Chapter 5 Global drug approval trends to 2012

Chapter 6 Appendix

List of Figures

List of Tables

For more information visit http://www.researchandmarkets.com/reports/c91636

Source: Business Insights

Source: Business Wire

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