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Appendix A: Timely and Effective Premarket Review – Updated FY 2007 Data

FY 2008 OCP Performance Report

The table below reflects 329 original applications for NDAs, BLAs, PMAs, 510(k)s, INDs, IDEs, and HDEs initially classified into one of nine categories of combination products received in FY 2007.

Number and Types of Combination Products

Application Type Combination Product Category Totals
1 2 3 4 5 6 7 8 9
Original NDAs 3 8 -- -- -- -- -- 2 -- 13
Original BLAs -- -- 3 -- -- -- -- -- -- 3
Original PMAs -- -- -- 4 -- -- -- -- 1 5
Original 510(k)s 4 -- -- 78 5 -- 3 -- 12 102
Original INDs 2 62 17 7 7 11 9 45 7 167
Original IDEs 2 -- 1 14 9 -- 7 3 2 38
Original HDEs -- -- -- -- 1 -- -- -- -- 1
Totals 11 70 21 103 22 11 19 50 22 329

APPLICATION KEY:
NDAs = New Drug Applications
BLAs = Biologics License Applications
PMAs = Premarket Approval Applications
510(k)s = Premarket Notifications
INDs = Investigational New Drug Applications
IDEs = Investigational Device Exemptions
HDEs = Humanitarian Device Exemptions

COMBINATION PRODUCT KEY:
1 = convenience kit or co-package
2 = prefilled drug delivery device/system
3 = prefilled biologic delivery device/system
4 = device coated/impregnated/otherwise combined with drug
5 = device coated or otherwise combined with biologic
6 = drug/biologic combination
7 = separate products requiring mutually conforming labeling
8 = possible combination based on mutually conforming labeling of separate products
9 = other type of combination product

Of the 329 original combination product applications, CBER received and categorized as combination products 40 applications; CDER received and categorized as combination products 144 applications; and CDRH categorized 145 applications as of September 30, 2008.