The FDA patted itself on the back for meeting its PDUFA review cycle targets (>90%) on New Drug Applications (NDAs) and Biologics License Applications (BLAs) for the past two years.
With PDUFA V just waiting to be signed by the President, the agency is supremely confident in its ability to keep the ball rolling. Through June 18th this year, CDER has approved a higher percentage of NME applications (12/15) - one third of these for rare diseases continuing a strong trend.
The median approval time for NMEs and NBEs reached 9.9 months in 2011 slightly bettering 10 months in 2010 and beating the 13 months seen in 2009 and 2008. Faster is better.
Posted by Bruce Lehr Jun 28th 2012