Slide of the month
• 87 drugs* approved between 2005 and 2008 were evaluated for mean time until approval following new drug application submission to the US FDA
• 75 products were reviewed and approved using the standard submission and approval process. The mean time to approval for these products was 456 days from submission (standard deviation of 384 days)
• 12 products were reviewed and approved using the accelerated approval process. The mean time to approval for these products was 216 days from submission (standard deviation of 73 days).
• 14 of the 87 products were granted fast-track designation; 9 of these were reviewed and approved using the standard process and 5 were reviewed and approved through the accelerated approval process. The mean time to approval for the fast-track designated products was 206 days from submission (standard deviation of 46 days)
• Products reviewed through accelerated routes were approved almost twice as fast as standard review
• Analysis of the post-approval history of these products indicated that there were no unexpected differences in labelling changes or other parameters indicative of safety issues, supporting the main purpose of the accelerated approval procedure: to bring safe and effective agents to market faster
* Drugs designated as vaccine or immunoglobulin were not included in this analysis.
This slide appeared as part of a poster presentation at the annual DIA Meeting in June 2011. Mr Meister and Ms Yuvasheva conducted this research independently as an elective part of their 5th year pharmacy (research) curriculum at Temple University, Philadelphia, Pennsylvania, USA. Their advisors were Dr David Lebo, Assistant Professor, Temple University and Lawrence Liberti, Executive Director, CIRS.
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