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U.S. Department of Health and Human Services

About FDA

FDA-TRACK

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: 33

ItemProgramOfficeStrategic PlanStrategic Goal/Area
12012 Small Clinical Trials CourseOSMPOffice of Orphan Products DevelopmentN/AN/A
2Membership and RecruitmentOSMPAdvisory Committee Oversight and Management StaffN/AN/A
3FY 2010 "Do a Designation" WorkshopOSMPOffice of Orphan Products DevelopmentN/AN/A
4Orphan Drug Designation Standard Operating Policy and Procedure (SOPP)OSMPOffice of Orphan Products DevelopmentN/AN/A
5Summary Report on the Pediatric Device Consortia Grant ProgramOSMPOffice of Orphan Products DevelopmentN/AN/A
6Humanitarian Use Device (HUD) GuidanceOSMPOffice of Orphan Products DevelopmentN/AN/A
7Use of Extrapolation of Efficacy in Products Granted Pediatric ExclusivityOSMPOffice of Pediatric TherapeuticsN/AN/A
8Use of Alternative Endpoints in Pediatric Clinical TrialsOSMPOffice of Pediatric TherapeuticsN/AN/A
9Number of presentations/participation at U.S. conferences, stakeholder meetings, and trainings during the monthOSMPOffice of Special Medical ProgramsN/AN/A
10Number of international outreach efforts during the monthOSMPOffice of Special Medical ProgramsN/AN/A
11Number of guidances and regulations issuedOSMPOffice of Special Medical ProgramsN/AN/A
12Percentage of RFD decisions issued in the month reviewed within 60 daysOSMPOffice of Combination ProductsN/AN/A
13Total number of RFDs filed by OCP in the monthOSMPOffice of Combination ProductsN/AN/A
14Total number of inquiries received by OGCP within the monthOSMPOffice of Good Clinical PracticeN/AN/A
15Total number of orphan drug designation reviews completed in the monthOSMPOffice of Orphan Products DevelopmentN/AN/A
16Percentage of orphan drug designation reviews completed in 90 days or lessOSMPOffice of Orphan Products DevelopmentN/AN/A
17Percentage of orphan drug designation reviews completed in 120 days or lessOSMPOffice of Orphan Products DevelopmentN/AN/A
18Total number of orphan drug designation decisions that resulted in orphan designation in the monthOSMPOffice of Orphan Products DevelopmentN/AN/A
19Total number of orphan drug approvals in the monthOSMPOffice of Orphan Products DevelopmentN/AN/A
20Total number of HUD designation reviews completed in the monthOSMPOffice of Orphan Products DevelopmentN/AN/A
21Percentage of HUD designation reviews completed in 45 days or lessOSMPOffice of Orphan Products DevelopmentN/AN/A
22Total number of HUD decisions that resulted in HUD designation in the monthOSMPOffice of Orphan Products DevelopmentN/AN/A
23Cumulative and total number of pediatric devices that were provided assistance by Pediatric Device Consortia in the quarterOSMPOffice of Orphan Products DevelopmentN/AN/A
24Grants Review WebsiteOSMPOffice of Orphan Products DevelopmentN/AN/A
25Number of internal safety meetings for pediatric products or issues in the monthOSMPOffice of Pediatric TherapeuticsN/AN/A
26Number of product safety assessment meetings coordinated for public review in the monthOSMPOffice of Pediatric TherapeuticsN/AN/A
27Number of medical products studied in children with pediatric safety labeling changes in the monthOSMPOffice of Pediatric TherapeuticsN/AN/A
28Number of Pediatric Advisory Committee (PAC) related activities in the monthOSMPOffice of Pediatric TherapeuticsN/AN/A
29Number of contacts with foreign regulators to discuss scientific, ethical or safety issues related to pediatrics in the monthOSMPOffice of Pediatric TherapeuticsN/AN/A
30Number of contacts with the Pediatric Review Committee (PeRC), the review divisions, and other FDA colleagues to provide Pediatric Investigation Plan (PIP) information to inform internal discussionsOSMPOffice of Pediatric TherapeuticsN/AN/A
31Number of presentations/participation at U.S. conferences, stakeholder meetings, and trainings during the monthOSMPOffice of Pediatric TherapeuticsN/AN/A
32Number of international outreach efforts during the monthOSMPOffice of Pediatric TherapeuticsN/AN/A
33Number of publicationsOSMPOffice of Pediatric TherapeuticsN/AN/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.