This report looks at how the FDA approval rates have changed in 2007 as compared to prior years. We have compiled data from the FDA as well as Sagient Research’s BioMedTracker and CatalystTracker products to analyze the numbers and draw our conclusions.

Data from the FDA’s website is used to look at the total number of original NDA and Efficacy Supplement NDAs (sNDAs) from 1999-2007. Data from BioMedTracker and CatalystTracker is used to look at the approval rate in 2007 versus 2006, as well as how stock price movements surrounding FDA approval decisions have changed year-over-year. Furthermore, we examine the decisions by disease group. Lastly, we take a look at what is to come in 2008.

For the full report, please download the PDF version at the top of this page.