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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: 23

ItemProgramOfficeStrategic PlanStrategic Goal/Area
1Number of scientific manuscripts published and external presentations developed facilitating development of MCMCBERN/ACBER Strategic PlanIncrease the nation's preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious diseases
2Enhance collaboration with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection CBERN/ACBER Strategic PlanImprove global public health through international collaboration including research and information sharing
3Engage in WHO pre-qualification of diagnostics pilot programme for HIV CBERN/ACBER Strategic PlanImprove global public health through international collaboration including research and information sharing
4Collaborate in the development of a standardized Factor XIa reference reagent for Immune Globulin Thrombogenicity Testing CBERN/ACBER Strategic PlanImprove global public health through international collaboration including research and information sharing
5Number of Original INDs and IDEs received and actions taken in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
6Number of marketing applications received and actions taken in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
7Number of efficacy supplements received and actions taken in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
8Number of BLA manufacturing supplements received and actions taken in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
9Number of Fast track designations granted in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
10Number of applications approved under Accelerated Approval in the quarter CBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
11Number of Priority Reviews completed in the quarter CBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
12Number of orphan drugs addressing rare diseases approved in the quarter CBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
13Number of PMRs and PMCs established during the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
14Number of meetings held and cancelled in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
15Number of meeting summaries issued in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
16Percentage 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 operationalCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
17Percentage of blood and blood component recalls classified by OCBQ under DRC, within 45 days of receipt of additional informationCBERN/ACBER Strategic PlanEnsure the safety of biological products
18Percentage of lot distribution reports received by OBE in the quarter that were entered into the RMS-BLA within 7 days CBERN/ACBER Strategic PlanEnsure the safety of biological products
19Number of site visits and number of site visit reports that are finalized in the quarter CBERN/ACBER Strategic PlanAdvance regulatory science and research
20Delivery and Installation of Critical Scientific Equipment at White Oak Facilities CBERN/ACBER Strategic PlanAdvance regulatory science and research
21Percentage of PMAPs for new CBER employees completed on-time, within 30 calendar days of action, during the monthCBERN/ACBER Strategic PlanManage for organizational excellence and accountability
22Percentage of advisory committee members and temporary voting members granted conflict of interest waivers during the quarterCBERN/ACBER Strategic PlanManage for organizational excellence and accountability
23CBER Participation in CBER Liaison and Roundtable Meetings with IndustryCBERN/ACBER Strategic PlanManage for 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.