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1 These activities are in addition to a wide range of OCP activities associated with its review of and response to Requests for Designation.
2 This is in accordance with section 503(g)(1) of the Act (21 U.S.C. 353(g)(1).
3 The RFD process, including the information required in a RFD submission, is outlined in 21 CFR Part 3.
4 This is by operation of section 563 of the Act (21 U.S.C. 360bbb-2).
5Includes one RFD that was pending at the beginning of the period.
6Does not include two requests for reconsideration for combination products that were issued within the 15-day time frame provided by 21 CFR 3.8.
7The “Number and Types of Combination Products” categorized for FY 2005 is updated in Appendix A.
8Only MDUFMA decision goals for expedited and original PMAs, 510(k)s, and BLAs are referenced in this report.
9Some product review goals, such as NDAs, are determined by months. Due to the fluctuation in days of individual months (28 to 31), 10 months ranges from 303 days (February 1 to December 1) to 306 days (March 15 to January 15) and 6 months ranges from 182 days (February 15 to August 15) to 184 days (July 15 to January 15).
10The decision goal is a goal on a final action, ending the review process. FDA decisions for PMAs are approval, approvable, approvable pending GMP inspection, not approvable, or denial.
11The number of combination product submissions is a small subset of the total number of submissions received by FDA.
12Major amendments were received within 3 months of the action due date, which extended the review time frames by 3 months for the following combination product submissions: 1 of 2 priority NDAs, the 1 of 1 priority BLA, and 3 of 10 standard NDAs.
13Median review time is based on FDA first cycle review performance. Actual review time was used when only one action was measured.
14FDA did not identify any MDUFMA-related BLA combination product submissions for FY 2005 and FY 2006.
15Performance goals apply to only a portion of applications of a certain type, and they do not require that every application be reviewed in accordance with the applicable time frame.
16Median review time is based on total FDA decision review time. Actual review time was used when only one action was measured.
17Some applications were associated with multiple consulting requests. Additionally, because these consulting requests are associated with any combination product under review for which consultative or collaborative review is needed, regardless of the date of FDA receipt of the application, the number of requests is not directly comparable to the number of combination product applications received during FY 2006, as reported in the previous section.
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This report was prepared by FDA's Office of Combination Products in collaboration with the Office of Planning, Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health. For information on obtaining additional copies contact: Office of Planning (HFP-10) This report is available on the FDA Home Page at http://www.fda.gov |