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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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Number of results:52

 ItemProgramOfficeStrategic PlanStrategic Goal/Area
1 Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submitted and approved CDER Office of New Drugs N/A Regulatory Review and Drug Safety
2 Number of New Molecular Entity (NME) NDAs and new BLAs submitted and approved CDER Office of New Drugs N/A Regulatory Review and Drug Safety
3 Number of NDA and BLA efficacy supplements submitted CDER Office of New Drugs N/A Regulatory Review and Drug Safety
4 Percentage of NDA related submissions in eCTD format and Total Number of NDA related submissions CDER Office of Strategic Programs N/A Regulatory Review and Drug Safety
5 Number of Fast Track designations, Accelerated Approval, Orphan Drugs for Rare Diseases, and First Generics granted/approved CDER Office of New Drugs N/A Regulatory Review and Drug Safety
6 Cumulative number of Presidential Emergency Plan for AIDS Relief (PEPFAR) drug approvals since 2004 CDER Office of New Drugs N/A Regulatory Review and Drug Safety
7 Number of pediatric studies completed (under both PREA and BPCA) and deferred (under PREA) CDER Office of New Drugs N/A Regulatory Review and Drug Safety
8 Number of biosimilar investigational new drug applications (INDs) received in the month CDER Office of New Drugs N/A Regulatory Review and Drug Safety
9 Number of initial advisory meeting requests received and meetings held in the month CDER Office of New Drugs N/A Regulatory Review and Drug Safety
10 Number of biosimilar biological product development (BPD) Type 1-4 meeting requests received and meetings held in the month CDER Office of New Drugs N/A Regulatory Review and Drug Safety
11 Cumulative number of biosimilar development programs in the BPD Program in the month CDER Office of New Drugs N/A Regulatory Review and Drug Safety
12 Number of 351(k) BLAs approved in the month CDER Office of New Drugs N/A Regulatory Review and Drug Safety
13 Number of core initial promotional campaign material reviews completed in the month and percentage completed within timeframe CDER Office of Prescription Drug Promotion N/A Regulatory Review and Drug Safety
14 Number of Postmarketing Requirements (PMRs) and Commitments(PMCs) established and fullfilled/released CDER Office of New Drugs N/A Regulatory Review and Drug Safety
15 Number of 18 month, ten thousand patient reviews initiated CDER Office of Surveillance and Epidemiology N/A Regulatory Review and Drug Safety
16 Number of Adverse Events (AE) reported for drugs/biological products CDER Office of Surveillance and Epidemiology N/A Regulatory Review and Drug Safety
17 Number of Risk Evaluation Mitigation Strategy (REMS) reviews, assessments, and approvals CDER Office of Surveillance and Epidemiology N/A Regulatory Review and Drug Safety
18 Number of pediatric safety reviews completed (BPCA, PREA, and Pediatric Rule) CDER Office of Surveillance and Epidemiology N/A Regulatory Review and Drug Safety
19 Percentage of complaints preliminarily reviewed and acknowledged within 30 days of receipt CDER Office of Prescription Drug Promotion N/A Drug Quality and Compliance
20 Number of recalls classified and products impacted by recall CDER Office of Compliance N/A Drug Quality and Compliance
21 Percentage of recall classifications meeting the 26 calendar-day timeframe in the month CDER Office of Compliance N/A Drug Quality and Compliance
22 Number of compounding recall events CDER Office of Compliance N/A Drug Quality and Compliance
23 Number of warning letters issued to compounders and 503B outsourcing facilities CDER Office of Compliance N/A Drug Quality and Compliance
24 Number of state referral letters issued concerning compounders CDER Office of Compliance N/A Drug Quality and Compliance
25 Number of injuctions/consent decrees against compounders and 503B outsourcing facilities CDER Office of Compliance N/A Drug Quality and Compliance
26 Total number of registered outsourcing facilities CDER Office of Compliance N/A Drug Quality and Compliance
27 Pilot Project Program under the Drug Supply Chain Security Act CDER Office of Compliance N/A Drug Quality and Compliance
28 Number of external presentations to Societies, Consortia, Industrial and Government organizations CDER Office of Communications N/A Transparency and Public Outreach
29 Number of Drug Safety Communications (DSCs) CDER Office of Communications N/A Transparency and Public Outreach
30 Number of presentations, interactions with sponsors, and interagency working group meetings for drug development CDER Office of Counter-Terrorism and Emergency Coordination N/A Transparency and Public Outreach
31 Rare Diseases Program CDER Office of New Drugs N/A Transparency and Public Outreach
32 Number of scientific and review publications published CDER All N/A Regulatory Science and Research
33 Number of guidances issued CDER Office of Regulatory Policy N/A Regulatory Science and Research
34 Number of inspections completed by personnel based in-country during the month by commodity OIP Office of International Programs N/A N/A
35 Number of guidances and regulations issued OSMP Office of Special Medical Programs N/A N/A
36 Percentage of RFD decisions issued in the month reviewed within 60 days OSMP Office of Combination Products N/A N/A
37 Total number of RFDs filed by OCP in the month OSMP Office of Combination Products N/A N/A
38 Total number of orphan drug designation reviews completed in the month OSMP Office of Orphan Products Development N/A N/A
39 Total number of orphan drug designation requests received in the month OSMP Office of Orphan Products Development N/A N/A
40 Percentage of orphan drug designation reviews completed in 120 days or less OSMP Office of Orphan Products Development N/A N/A
41 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
42 Total number of orphan drug approvals in the month OSMP Office of Orphan Products Development N/A N/A
43 Number of internal and external safety and product assessment meetings in the month OSMP Office of Pediatric Therapeutics N/A N/A
44 Number of medical products studied in children with pediatric safety labeling changes in the month OSMP Office of Pediatric Therapeutics N/A N/A
45 Number of Pediatric Advisory Committee (PAC) related activities in the month OSMP Office of Pediatric Therapeutics N/A N/A
46 Number of activities OSMP Office of Pediatric Therapeutics N/A N/A
47 Number of Neonatal-Perinatal Medicine consultations or reviews OSMP Office of Pediatric Therapeutics N/A N/A
48 Number of contacts and meetings with foreign regulators to discuss scientific, ethical or safety issues related to pediatrics in the month OSMP Office of Pediatric Therapeutics N/A N/A
49 Number of EMA Pediatric Investigation Plans (PIPs) that are matched with PeRC's products/requested by FDA divisions OSMP Office of Pediatric Therapeutics N/A N/A
50 Number of presentations/participation at U.S. conferences, stakeholder meetings, and trainings during the month OSMP Office of Pediatric Therapeutics N/A N/A
51 Number of international outreach efforts during the month OSMP Office of Pediatric Therapeutics N/A N/A
52 Number of publications 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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