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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:22

 ItemProgramOfficeStrategic PlanStrategic Goal/Area
1 Number of scientific manuscripts published and external presentations developed facilitating development of MCM CBER N/A CBER Strategic Plan Increase preparedness for emerging threats and promote global public health
2 Engage in WHO pre-qualification of diagnostics pilot programme for HIV CBER N/A CBER Strategic Plan Increase preparedness for emerging threats and promote global public health
3 Collaborate in the development of a standardized Factor XIa reference reagent for Immune Globulin Thrombogenicity Testing CBER N/A CBER Strategic Plan Increase preparedness for emerging threats and promote global public health
4 Number of Original INDs and IDEs received and actions taken in the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
5 Number of marketing applications received and actions taken in the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
6 Number of efficacy supplements received and actions taken in the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
7 Number of BLA manufacturing supplements received and actions taken in the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
8 Number of Fast track designations granted in the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
9 Number of applications approved under Accelerated Approval in the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
10 Number of Priority Reviews completed in the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
11 Number of orphan drugs addressing rare diseases approved in the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
12 Number of Breakthrough Therapy Requests Received, Approvals, and Withdrawn After Granting (WAG) and Rescinded CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
13 Number of PMRs and PMCs established during the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
14 Number of meetings held and cancelled in the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
15 Number of meeting summaries issued in the quarter CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
16 Percentage of approval letters reviewed for disclosure and posted on the web within 5 business days of receipt in OCOD, excluding days that the Web Content Management System (WCMS) is not operational CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
17 Percentage of biological product recalls classified by OCBQ under DRC, within 45 days of receipt of additional information CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
18 Percentage of lot distribution reports received by OBE in the quarter that were entered into the RMS-BLA within 7 days CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
19 Review of Adverse Event Reports CBER N/A CBER Strategic Plan Facilitate the development and availability of safe and effective medical products through the integration of advances in science and technology
20 Number of site visits and number of site visit reports that are finalized in the quarter CBER N/A CBER Strategic Plan Conduct research to address challenges in the development and regulatory evaluation of medical products
21 Percentage of PMAPs for new CBER employees completed on-time, within 30 calendar days of action, during the month CBER N/A CBER Strategic Plan Manage for strategic organizational excellence and accountability
22 Percentage of advisory committee members and temporary voting members granted conflict of interest waivers during the quarter CBER N/A CBER Strategic Plan Manage for strategic organizational excellence and accountability

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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