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OCP FY 2005 Combination Product Applications

The vertical stacked column graph presents the number of CBER, CDER, and CDRH combination product applications submitted for FY 2003, FY 2004, and FY 2005. The scale is in increments of 50 with a ceiling of 300. It shows that the total number of combination products submitted was slightly less than 100 in FY 2003. However, it is footnoted that for FY 2003 the numbers do not represent all of FY 2003 and that FDA began data collection on April 1, 2003. While the proportion of submissions appeared relatively the same between the three centers in FY 2003, the graph showed CDRH to have the most, followed by CDER and CBER, respectively. During FY 2004, the total number of combination product applications submitted for review more than doubled to just under 250. CDER and CDRH appeared to have most of the submissions with slightly over 200 of them. CDER and CDRH also appeared to roughly have the same proportion relative to each other, with CDER having slightly more. During FY 2005, the total number of combination product applications under review grew slightly to approximately 275. The relative proportions of the submissions in FY 2005 appeared similar to FY 2004; however, the number of CBER submissions appeared to go down slightly while both CDER and CDRH increased slightly.


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