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

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.

Read more...

• Genzyme (11/09/2009)
• Prasugrel (20/07/2009)
• Novartis's Afinitor (09/04/2009)

• Pirates and Corsairs (29/04/2008)
• First FarmavitaR+ / regulanet conference (02/02/2008)
• Centralised Procedure - Turkey (02/02/2008)
• Administrative Fees - Romania (22/01/2008)
• Administrative Fees - The Czech R. (10/12/2007)
• Regulatory bodies and truth about cosmetic ingredients (06/11/2007)
• New RA Alliance (27/09/2007)
• Strategic RA Consulting (20/09/2007)
• Readability (QRD) Testing (04/06/2007)

---