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U.S. Department of Health and Human Services

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OCP FY 2006 Combination Product Applications

The vertical stacked column graph presents the number of CBER, CDER, and CDRH combination product applications submitted from FY 2003 through FY 2006. The scale is in increments of 50 with a range from 0 to 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 appears 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 fewer than 250. CDER and CDRH had most of the submissions at slightly above 200. 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 decrease slightly while both CDER and CDRH increased slightly. During FY 2006, the total number of combination product applications submitted decreased to slightly more than 230. The majority of this decrease was in the number of combination products submitted for review to CDER. CDER’s and CDRH’s proportion of total combination product applications fell from the FY 2005 levels, while CBER’s proportion  slightly increased. CDER and CDRH had most of the submissions at nearly 200, while CDER and CDRH also had roughly the same proportion relative to each other, with CDER having slightly more.

 

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