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


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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 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...


Top five reasons to order your copy today
• Examine the latest developments in US and European drug approval processes with this report’s detailed analysis of the key regulatory issues surrounding new molecular entities, generic drug applications, indication expansions and drug safety.

• Understand the implications of rising adverse drug reactions by exploring the issues surrounding safety failures and measuring the potentially affected patient populations of recent discontinuations.

• Measure the future impact of drug approval trends on R&D programs using this report’s extensive review of anticipated changes to FDA and EMEA approval frameworks over the 2008-12 period.

• Evaluate the strategies that companies are using to accelerate drug approvals by understanding the latest industrial approaches to safety test improvements, outsourcing, repositioning and the management of clinical study results and data reporting.

• Benchmark successful drug applications and avoid approval delays with this report’s case studies featuring numerous profiles for issues such as risky drug applications, biosimilar approvals and Rx-to OTC switches.


Key issues examined in this report...
• Delayed approvals. Regulators are requesting more data to validate or refute conclusions about product risks. This is creating a rise in the size and number of clinical trials as well as overall research budgets.

• Rising R&D costs. Drug developers are continually increasing their R&D expenditures to generate approvable drug applications, despite rising financial pressures in the industry. Emerging technologies such as stem cells, genomics and proteomics are among the most prevalent initiatives being used to identify appropriate drug candidates.

• US generics focus. The FDA is allocating resources to generic drug approvals in an attempt to speed these products to market. However, although Europe has recently developed a clear regulatory path for generic versions of biologicals, this is yet be achieved in the US.

• Regulatory process improvements. Regulators are enhancing their drug review processes with new technologies such as electronic drug applications and technology-based standards for drug review.

Your questions answered...
• Why are new molecular entities experiencing growing approval delays?

• How is the FDA responding to allegations that reviewers are being influenced by the intense pressure to approve new products?

• In which therapy areas are the FDA currently showing the greatest flexibility for novel product approval?

• How will the FDA encourage Rx-to-OTC switches of novel medicines?

• What technologies are drug makers utilizing to help speed the drug development process?

• What new processes has the EMEA recently established to significantly speed drug approvals?

• What emerging trends are companies using to bypass early-stage drug testing?

• How has the convergence of FDA and EMEA approaches benefited European drug marketers?