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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: 29

ItemProgramOfficeStrategic PlanStrategic Goal/Area
1Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submitted and approved CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
2Number of New Molecular Entity (NME) NDAs and new BLAs submitted and approved CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
3Number of NDA and BLA efficacy supplements submitted CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
4Percentage of NDA related submissions in eCTD format and Total Number of NDA related submissions CDEROffice of Planning and InformaticsN/ARegulatory Review and Drug Safety
5Number of Fast Track designations granted, Accelerated Approval, Priority Reviews, and First Generics CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
6Cumulative number of Presidential Emergency Plan for AIDS Relief (PEPFAR) drug approvals since 2004 CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
7Number of pediatric studies completed (under both PREA and BPCA) and deferred (under PREA) CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
8Number of biosimilar investigational new drug applications (INDs) received in the month CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
9Number of initial advisory meeting requests received and meetings held in the month CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
10Number of biosimilar biological product development (BPD) Type 1-4 meeting requests received and meetings held in the month CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
11Cumulative number of biosimilar development programs in the BPD Program in the month CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
12Number of core initial promotional campaign material reviews completed in the month and percentage completed within timeframe CDEROffice of Prescription Drug PromotionN/ARegulatory Review and Drug Safety
13Number of Postmarketing Requirements (PMRs) and Commitments(PMCs) established and fullfilled/released CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
14Number of 18 month, ten thousand patient reviews initiated CDEROffice of Surveillance and EpidemiologyN/ARegulatory Review and Drug Safety
15Number of Adverse Events (AE) reported for drugs/biological products CDEROffice of Surveillance and EpidemiologyN/ARegulatory Review and Drug Safety
16Number of Risk Evaluation Mitigation Strategy (REMS) reviews, assessments, and approvals CDEROffice of Surveillance and EpidemiologyN/ARegulatory Review and Drug Safety
17Number of pediatric safety reviews completed (BPCA, PREA, and Pediatric Rule) CDEROffice of Surveillance and EpidemiologyN/ARegulatory Review and Drug Safety
18Number and Percentage of complaints preliminarily reviewed and acknowledged within 30 days of receipt CDEROffice of Prescription Drug PromotionN/ADrug Quality and Compliance
19Number of recalls classified and products impacted by recall CDEROffice of ComplianceN/ADrug Quality and Compliance
20Percentage of recall classifications meeting 26 calendar-day timeframe in the month CDEROffice of ComplianceN/ADrug Quality and Compliance
21Number of actions to remove unapproved drugs from marketplace CDEROffice of ComplianceN/ADrug Quality and Compliance
22Number of warning letters issued for unapproved drugs that are not part of the class actions CDEROffice of ComplianceN/ADrug Quality and Compliance
23Number of seizures or injunctions issued for unapproved drugs CDEROffice of ComplianceN/ADrug Quality and Compliance
24Number of external presentations to Societies, Consortia, Industrial and Government organizations CDEROffice of CommunicationsN/ATransparency and Public Outreach
25Number of Drug Safety Communications (DSCs) CDEROffice of CommunicationsN/ATransparency and Public Outreach
26Number of presentations, interactions with sponsors, and interagency working group meetings for drug development CDEROffice of Counter-Terrorism and Emergency CoordinationN/ATransparency and Public Outreach
27Rare Diseases Program CDEROffice of New DrugsN/ATransparency and Public Outreach
28Number of scientific and review publications published CDEROffice of Testing and ResearchN/ARegulatory Science and Research
29Number of guidances issued CDEROffice of Regulatory PolicyN/ARegulatory Science and Research

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.