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U.S. Department of Health and Human Services

About FDA

FDA-TRACK Archive

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 current FDA-TRACK performance measures and projects view the Active Index

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Results

Number of results: 94

ItemProgramOfficeFY
Completed
Strategic PlanStrategic Goal/Area
1Total submissions routed to drug reviewCDEROffice of Strategic Programs2013N/AN/A
2Percent of NDA related submissions in eCTD format in the monthCDEROffice of Strategic Programs2013N/AN/A
3Prescription Drug User Fee Act (PDUFA) ReauthorizationCDEROffice of Strategic Programs2012N/AN/A
4Percent of CDER positions staffedCDEROffice of Management2013N/AN/A
5Percent of CDER employees who reported 100% of their time during the quarterCDEROffice of Management2013N/AN/A
6Establish a CDER/NTEU Labor Management Council in Compliance with E.O. 13522CDEROffice of Management2012N/AN/A
7Create Project Roadmap for CDER/NTEU Labor Management CouncilCDEROffice of Management2010N/AN/A
8Percentage of 505(q) petition responses due in the month, completed by deadlineCDEROffice of Regulatory Policy2013N/AN/A
9Employee DevelopmentCDEROffice of Regulatory Policy2011N/AN/A
10Number of drugs Advisory Committee meetings held that monthCDEROffice of Executive Programs2013N/AN/A
11Number of Congressional correspondence requests received, GAO and IG assignments managed, and international inquiries received that monthCDEROffice of Executive Programs2013N/AN/A
12Number of completed training activities that monthCDEROffice of Executive Programs2011N/AN/A
13Equal Voice and Dispute ResolutionCDEROffice of Executive Programs2011N/AN/A
14Total number of Public Inquiries by month (includes phone, email, and letter inquiries)CDEROffice of Communications2013N/AN/A
15Total number of training events in the monthCDERN/A2013N/AN/A
16Total number of CDER employees who completed the training events in the monthCDERN/A2013N/AN/A
17Number of IND submissions and amendments evaluated and reviews completed within the monthCDEROffice of Biotechnology Products2013N/AN/A
18Number of NDA and BLA reviews completed and signed off within the monthCDEROffice of Biotechnology Products2013N/AN/A
19Number of NDA and BLA supplement reviews completed and signed off within the monthCDEROffice of Biotechnology Products2013N/AN/A
20Number of product manufacturing facilities site inspections and inspection related meetings which occurred during the monthCDEROffice of Biotechnology Products2013N/AN/A
21Number of correspondences with applicants associated with INDs, BLAs, NDAs, sNDAs or sBLAs which occurred within the monthCDEROffice of Biotechnology Products2013N/AN/A
22Number of industry meetings attended and number of OBP-managed product quality meetings held within the monthCDEROffice of Biotechnology Products2013N/AN/A
23Number of external presentations to Societies, Consortia, Industrial and Government administered by OBP staff within the monthCDEROffice of Biotechnology Products2013N/AN/A
24Number of Scientific and Review Publications published within the monthCDEROffice of Biotechnology Products2013N/AN/A
25Implementation of Quality Management System (QMS) for Chemistry, Manufacturing, and Controls (CMC) ReviewCDEROffice of Biotechnology Products2013N/AN/A
26Percentage of completed reviews of core initial promotional campaign materials performed within 45 days, subtracting out the time period of medical consultation, if any, from overall review time.CDEROffice of Prescription Drug Promotion2013N/AN/A
27Total 2253 pieces (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use) receivedCDEROffice of Prescription Drug Promotion2013N/AN/A
28Complaint letters received and reviewed regarding promotion materials in the monthCDEROffice of Prescription Drug Promotion2013N/AN/A
29Direct to Consumer MonitoringCDEROffice of Prescription Drug Promotion2012N/AN/A
30Number of Warning Letter recommendations, Seizure actions, Disqualifications, and Injunction packages reviewed in the monthCDEROffice of Compliance2013N/AN/A
31Number of class actions taken and Seizures or Injunctions issued in the quarter for unapproved drugsCDEROffice of Compliance2013N/AN/A
32Total number of recall events in the month for which the classification process was completed (includes recalls by Class and number of products impacted)CDEROffice of Compliance2013N/AN/A
33Number of new inquires received in the monthCDEROffice of Compliance2013N/AN/A
34Number of Warning Letters issued in the quarter for unapproved drugsCDEROffice of Compliance2013N/AN/A
35Number of export certificate requests received and issued in the monthCDEROffice of Compliance2011N/AN/A
36Number of presentations performed in the monthCDEROffice of Compliance2013N/AN/A
37Compliance Program (CP) UpdatesCDEROffice of Compliance2011N/AN/A
38Compliance Program (CP) Updates - ImplementationCDEROffice of Compliance2013N/AN/A
39Number of new research studies initiated within the monthCDEROffice of Testing and Research2013N/AN/A
40Number of direct data communications, interim technical reports, and final technical reports with Review/Policy Divisions in the monthCDEROffice of Testing and Research2013N/AN/A
41Assessment of histopathology practices in biomarker qualificationCDEROffice of Testing and Research2013N/AN/A
42Marketplace QualityCDEROffice of Testing and Research2011N/AN/A
43Characterization of Biologically Derived Drug ProductsCDEROffice of Testing and Research2013N/AN/A
44Pediatric Platform TechnologiesCDEROffice of Testing and Research2013N/AN/A
45Rapid Screening of PharmaceuticalsCDEROffice of Testing and Research2010N/AN/A
46Quality Assessment of Repackaged ProductsCDEROffice of Testing and Research2010N/AN/A
47Number of New Bioequivalence Recommendations Posted in the monthCDEROffice of Generic Drugs2013N/AN/A
48The number meetings with industry to provide guidance, presentations made to external organizations, and guidances initiatedCDEROffice of Generic Drugs2013N/AN/A
49Number of applications received, applications pending, and actions takenCDEROffice of Generic Drugs2013N/AN/A
50Generic drug switch study with National Institutes of Health (NIH) / National Institute of Neurological Disorders and Stroke (NINDS) (epilepsy products)CDEROffice of Generic Drugs2011N/AN/A
51Study of anti-depressant generic drug switches with Company X2CDEROffice of Generic Drugs2011N/AN/A
52Quality by Design RoadmapCDEROffice of Generic Drugs2011N/AN/A
53Improving the Generic Drug Review Process and Review Queue ManagementCDEROffice of Generic Drugs2013N/AN/A
54Number of Commercial and Research INDs received in the monthCDEROffice of New Drugs2013N/AN/A
55Actions taken on marketing applications on time and past goal dates and the number of marketing applications receivedCDEROffice of New Drugs2013N/AN/A
56Actions taken on efficacy supplements on time and past goal dates and the number of marketing applications receivedCDEROffice of New Drugs2013N/AN/A
57Number of Postmarket Requirements (PMR) and Commitments (PMC) established and completed in the monthCDEROffice of New Drugs2013N/AN/A
5821st Century ReviewCDEROffice of New Drugs2011N/AN/A
59Professional Development TrainingCDEROffice of New Drugs2013N/AN/A
60Number of written Chemistry, Manufacturing, and Controls (CMC) reviews completed for INDs by ONDQA during the monthCDEROffice of New Drug Quality Assessment2013N/AN/A
61Number of written Chemistry, Manufacturing, and Controls (CMC) reviews completed for NDAs by ONDQA during the monthCDEROffice of New Drug Quality Assessment2013N/AN/A
62Number of written Chemistry, Manufacturing, and Controls (CMC) reviews completed for NDA supplements by ONDQA during the monthCDEROffice of New Drug Quality Assessment2013N/AN/A
63The number of written Drug Master File reviews completed by ONDQA during the monthCDEROffice of New Drug Quality Assessment2013N/AN/A
64Number of ONDQA correspondences with applicants associated with the CMC review of INDs, NDAs, or sNDAs occurred within the monthCDEROffice of New Drug Quality Assessment2013N/AN/A
65Number of ONDQA -managed product quality meetings held with sponsors in the monthCDEROffice of New Drug Quality Assessment2013N/AN/A
66Number of external presentations by ONDQA staff with professional societies, consortia, academia, or other government entity in the monthCDEROffice of New Drug Quality Assessment2013N/AN/A
67Percentage of New Drug Applications (NDAs) for new molecular entities (NMEs) containing QbD elements. Cumulative total reported for the Fiscal Year.CDEROffice of New Drug Quality Assessment2013N/AN/A
68Percentage of New Drug Applications (NDAs) containing QbD elements (NME and non-NME). Cumulative total reported each Fiscal Year.CDEROffice of New Drug Quality Assessment2013N/AN/A
69Percentage of meetings with sponsors that include discussion of QbD information. Cumulative total reported for the Fiscal Year.CDEROffice of New Drug Quality Assessment2013N/AN/A
70Implementation of Quality Management System (QMS) for CMC ReviewCDEROffice of New Drug Quality Assessment2013N/AN/A
71Number of 18 month, ten thousand patient reviews inititated in the month(New Molecular Entities (NME) and non-NMEs)CDEROffice of Surveillance and Epidemiology2013N/AN/A
72Number of manufacturer AE reports received in the month and the percentage received electronicallyCDEROffice of Surveillance and Epidemiology2013N/AN/A
73Number of direct-to-FDA AE reports received in the month and the percentage received electronicallyCDEROffice of Surveillance and Epidemiology2013N/AN/A
74Percent electronic-based expedited reports received in the month compared to paper-based expedited reportsCDEROffice of Surveillance and Epidemiology2013N/AN/A
75Initial REMS reviews completed, REMS assessments completed, and REMS approved in the monthCDEROffice of Surveillance and Epidemiology2013N/AN/A
76Number of reviews completed under the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Research Equity Act (PREA), and the Pediatric RuleCDEROffice of Surveillance and Epidemiology2013N/AN/A
77Safety FirstCDEROffice of Surveillance and Epidemiology2013N/AN/A
7818 Month, Ten Thousand Patient ReviewsCDEROffice of Surveillance and Epidemiology2010N/AN/A
79Number of Incoming NDAs, BLAs, and Efficacy Supplements with electronic datasets received and the percent received with data in SDTM and ADaM formatsCDEROffice of Biostatistics2013N/AN/A
80Number of submissions with electronic datasets reaching mid-cycle review during the monthCDEROffice of Biostatistics2013N/AN/A
81Number of voluntary exploratory data submissions (VXDS) and biomarker qualification reviews completed per monthCDEROffice of Clinical Pharmacology2010N/AN/A
82Number of genomics Investigational New Drug (IND) and New Drug Application (NDA)/Biologics License Application (BLA) reviews completed per monthCDEROffice of Clinical Pharmacology2013N/AN/A
83Number of pharmacometrics IND and NDA/BLA reviews completed per monthCDEROffice of Clinical Pharmacology2013N/AN/A
84Number of pediatrics study reviews completed per monthCDEROffice of Clinical Pharmacology2013N/AN/A
85The number of cross-discipline reviews led by OCP as cross-disciplinary team leaders (CDTLs)CDEROffice of Clinical Pharmacology2013N/AN/A
86Total number of industry meetings that OCP leads related to for example, guidances, End-of-Phase 2A (EOP2A) requests, EOP2 meetings, Voluntary Exploratory Data Submission (VXDS) and biomarkers meetings attended per monthCDEROffice of Clinical Pharmacology2013N/AN/A
87Total number of internal pediatric review committee meetings attended per monthCDEROffice of Clinical Pharmacology2013N/AN/A
88Total number Clinical Pharmacology Advisory Committee meetings and OCP Co-sponsor meetings (i.e. Drug Information Association (DIA), Pharmaceutical Research and Manufacturers of America (PhRMA)) that OCP co-organizes and presents per monthCDEROffice of Clinical Pharmacology2010N/AN/A
89Total number of new labels (postmarketing) approved in the month that include clinical pharmacology review on pharmacogenetic, drug-drug interactions and specific population information, etc.CDEROffice of Clinical Pharmacology2013N/AN/A
90Characterization of Biologically Derived Drug Products CDEROffice of Testing and Research2014N/ARegulatory Review and Drug Safety
91Number of seizures or injunctions issued for unapproved drugs CDEROffice of Compliance2014N/ADrug Quality and Compliance
92Number of actions to remove unapproved drugs from marketplace CDEROffice of Compliance2014N/ADrug Quality and Compliance
93Number of warning letters issued for unapproved drugs that are not part of the class actions CDEROffice of Compliance2014N/ADrug Quality and Compliance
94Number of seizures or injunctions issued for unapproved drugs CDEROffice of Compliance2014N/ADrug Quality and Compliance

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.