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U.S. Department of Health and Human Services

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FDA-TRACK Active

The list below provides information on FDA's performance measures and projects as aligned to FDA strategic priorities and program offices. This list enables you to view charts of performance data and progress on important projects and programs.

To view completed FDA-TRACK performance measures and projects view the Archive Index

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Results

Number of results:46

 ItemProgramOfficeStrategic PlanStrategic Goal/Area
1 Percentage of RFD decisions issued in the month reviewed within 60 days OSMP Office of Combination Products N/A N/A
2 Total number of RFDs filed by OCP in the month OSMP Office of Combination Products N/A N/A
3 Percentage of informal requests issued within 60 days OSMP Office of Combination Products N/A N/A
4 Total number of orphan drug designation reviews completed in the month OSMP Office of Orphan Products Development N/A N/A
5 Total number of orphan drug designation requests received in the month OSMP Office of Orphan Products Development N/A N/A
6 Percentage of orphan drug designation reviews completed in 120 days or less OSMP Office of Orphan Products Development N/A N/A
7 Total number of orphan drug designation decisions that resulted in orphan designation in the month OSMP Office of Orphan Products Development N/A N/A
8 Total number of orphan drug approvals in the month OSMP Office of Orphan Products Development N/A N/A
9 Total number of HUD designation reviews completed in the month OSMP Office of Orphan Products Development N/A N/A
10 Total number of HUD designation requests received in the month OSMP Office of Orphan Products Development N/A N/A
11 Percentage of HUD designation reviews completed in 45 days or less OSMP Office of Orphan Products Development N/A N/A
12 Total number of HUD decisions that resulted in HUD designation in the month OSMP Office of Orphan Products Development N/A N/A
13 Total number of RPD direct and consult requests received in the month OSMP Office of Orphan Products Development N/A N/A
14 Percentage of 60-day statutory deadlines met for RPD designation requests in the month OSMP Office of Orphan Products Development N/A N/A
15 Total number of RPD direct and consult requests granted in the month OSMP Office of Orphan Products Development N/A N/A
16 Total number of grant applications received OSMP Office of Orphan Products Development N/A N/A
17 Total number of grant panels convened OSMP Office of Orphan Products Development N/A N/A
18 Total number of grants awarded per month OSMP Office of Orphan Products Development N/A N/A
19 Estimated average number of reports received for active grants per month OSMP Office of Orphan Products Development N/A N/A
20 Number of presentations/participation at U.S. conferences, stakeholder meetings, and trainings in the month OSMP Office of Pediatric Therapeutics N/A N/A
21 Number of internal meetings to plan for external meetings in the month OSMP Office of Pediatric Therapeutics N/A N/A
22 Number of international outreach efforts in the month OSMP Office of Pediatric Therapeutics N/A N/A
23 Number of publications in the month OSMP Office of Pediatric Therapeutics N/A N/A
24 Number of internal and external safety and product assessment meetings in the month OSMP Office of Pediatric Therapeutics N/A N/A
25 Number of Literature Reviews in the month OSMP Office of Pediatric Therapeutics N/A N/A
26 Number of medical products studied in children with pediatric safety labeling changes in the month OSMP Office of Pediatric Therapeutics N/A N/A
27 Number of conflict of interest (COI) matters completed in the month OSMP Office of Pediatric Therapeutics N/A N/A
28 Number of Federal Register (FR) Notices published in the month OSMP Office of Pediatric Therapeutics N/A N/A
29 Number of Federal Register (FR) Notices amended in the month OSMP Office of Pediatric Therapeutics N/A N/A
30 Number of contracts drafted in the month OSMP Office of Pediatric Therapeutics N/A N/A
31 Number of contracts amended in the month OSMP Office of Pediatric Therapeutics N/A N/A
32 Number of meeting travel authorizations created in the month OSMP Office of Pediatric Therapeutics N/A N/A
33 Number of meeting travel vouchers granted in the month OSMP Office of Pediatric Therapeutics N/A N/A
34 Number of personnel actions for Special Government Employees (SGEs) and Pediatric Advisory Committee (PAC) Members in the month OSMP Office of Pediatric Therapeutics N/A N/A
35 Number of additional experts contacted in the month OSMP Office of Pediatric Therapeutics N/A N/A
36 Number of PAC Meetings held in the month OSMP Office of Pediatric Therapeutics N/A N/A
37 Number of PAC Meeting days in the month OSMP Office of Pediatric Therapeutics N/A N/A
38 Number of PAC Joint Meetings with other divisions in the month OSMP Office of Pediatric Therapeutics N/A N/A
39 Number of 50.54 Meetings in the month OSMP Office of Pediatric Therapeutics N/A N/A
40 Number of activities in the month OSMP Office of Pediatric Therapeutics N/A N/A
41 Number of Neonatal-Perinatal Medicine consultations or reviews OSMP Office of Pediatric Therapeutics N/A N/A
42 Number of Pediatric Ethics consultations or reviews in the month OSMP Office of Pediatric Therapeutics N/A N/A
43 Number of meetings to develop or revise pediatric/ethics guidance in the month OSMP Office of Pediatric Therapeutics N/A N/A
44 Number of oral communications, including meetings, with foreign regulators to discuss pediatric product development in the month OSMP Office of Pediatric Therapeutics N/A N/A
45 Number of EMA Pediatric Investigation Plans (PIPs) that are matched with PeRC's products/requested by FDA divisions in the month OSMP Office of Pediatric Therapeutics N/A N/A
46 Number of EMA Pediatric Investigation Plans (PIPs) that are matched with the Oncology Subcommittee of PeRC products requested by FDA in the month OSMP Office of Pediatric Therapeutics N/A N/A

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information in the Archive Index may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.


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