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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: 126

ItemProgramOfficeStrategic PlanStrategic Goal/Area
1Total submissions routed to drug reviewCDEROffice of Strategic ProgramsN/AN/A
2Percent of NDA related submissions in eCTD format in the monthCDEROffice of Strategic ProgramsN/AN/A
3Prescription Drug User Fee Act (PDUFA) ReauthorizationCDEROffice of Strategic ProgramsN/AN/A
4Percent of CDER positions staffedCDEROffice of ManagementN/AN/A
5Percent of CDER employees who reported 100% of their time during the quarterCDEROffice of ManagementN/AN/A
6Establish a CDER/NTEU Labor Management Council in Compliance with E.O. 13522CDEROffice of ManagementN/AN/A
7Create Project Roadmap for CDER/NTEU Labor Management CouncilCDEROffice of ManagementN/AN/A
8Percentage of 505(q) petition responses due in the month, completed by deadlineCDEROffice of Regulatory PolicyN/AN/A
9Employee DevelopmentCDEROffice of Regulatory PolicyN/AN/A
10Number of drugs Advisory Committee meetings held that monthCDEROffice of Executive ProgramsN/AN/A
11Number of Congressional correspondence requests received, GAO and IG assignments managed, and international inquiries received that monthCDEROffice of Executive ProgramsN/AN/A
12Number of completed training activities that monthCDEROffice of Executive ProgramsN/AN/A
13Equal Voice and Dispute ResolutionCDEROffice of Executive ProgramsN/AN/A
14Total number of Public Inquiries by month (includes phone, email, and letter inquiries)CDEROffice of CommunicationsN/AN/A
15Total number of training events in the monthCDERN/AN/AN/A
16Total number of CDER employees who completed the training events in the monthCDERN/AN/AN/A
17Number of IND submissions and amendments evaluated and reviews completed within the monthCDEROffice of Biotechnology ProductsN/AN/A
18Number of NDA and BLA reviews completed and signed off within the monthCDEROffice of Biotechnology ProductsN/AN/A
19Number of NDA and BLA supplement reviews completed and signed off within the monthCDEROffice of Biotechnology ProductsN/AN/A
20Number of product manufacturing facilities site inspections and inspection related meetings which occurred during the monthCDEROffice of Biotechnology ProductsN/AN/A
21Number of correspondences with applicants associated with INDs, BLAs, NDAs, sNDAs or sBLAs which occurred within the monthCDEROffice of Biotechnology ProductsN/AN/A
22Number of industry meetings attended and number of OBP-managed product quality meetings held within the monthCDEROffice of Biotechnology ProductsN/AN/A
23Number of external presentations to Societies, Consortia, Industrial and Government administered by OBP staff within the monthCDEROffice of Biotechnology ProductsN/AN/A
24Number of Scientific and Review Publications published within the monthCDEROffice of Biotechnology ProductsN/AN/A
25Implementation of Quality Management System (QMS) for Chemistry, Manufacturing, and Controls (CMC) ReviewCDEROffice of Biotechnology ProductsN/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 PromotionN/AN/A
27Total 2253 pieces (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use) receivedCDEROffice of Prescription Drug PromotionN/AN/A
28Complaint letters received and reviewed regarding promotion materials in the monthCDEROffice of Prescription Drug PromotionN/AN/A
29Direct to Consumer MonitoringCDEROffice of Prescription Drug PromotionN/AN/A
30Number of Warning Letter recommendations, Seizure actions, Disqualifications, and Injunction packages reviewed in the monthCDEROffice of ComplianceN/AN/A
31Number of class actions taken and Seizures or Injunctions issued in the quarter for unapproved drugsCDEROffice of ComplianceN/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 ComplianceN/AN/A
33Number of new inquires received in the monthCDEROffice of ComplianceN/AN/A
34Number of Warning Letters issued in the quarter for unapproved drugsCDEROffice of ComplianceN/AN/A
35Number of export certificate requests received and issued in the monthCDEROffice of ComplianceN/AN/A
36Number of presentations performed in the monthCDEROffice of ComplianceN/AN/A
37Compliance Program (CP) UpdatesCDEROffice of ComplianceN/AN/A
38Compliance Program (CP) Updates - ImplementationCDEROffice of ComplianceN/AN/A
39Number of new research studies initiated within the monthCDEROffice of Testing and ResearchN/AN/A
40Number of direct data communications, interim technical reports, and final technical reports with Review/Policy Divisions in the monthCDEROffice of Testing and ResearchN/AN/A
41Assessment of histopathology practices in biomarker qualificationCDEROffice of Testing and ResearchN/AN/A
42Marketplace QualityCDEROffice of Testing and ResearchN/AN/A
43Characterization of Biologically Derived Drug ProductsCDEROffice of Testing and ResearchN/AN/A
44Pediatric Platform TechnologiesCDEROffice of Testing and ResearchN/AN/A
45Rapid Screening of PharmaceuticalsCDEROffice of Testing and ResearchN/AN/A
46Quality Assessment of Repackaged ProductsCDEROffice of Testing and ResearchN/AN/A
47Number of New Bioequivalence Recommendations Posted in the monthCDEROffice of Generic DrugsN/AN/A
48The number meetings with industry to provide guidance, presentations made to external organizations, and guidances initiatedCDEROffice of Generic DrugsN/AN/A
49Number of applications received, applications pending, and actions takenCDEROffice of Generic DrugsN/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 DrugsN/AN/A
51Study of anti-depressant generic drug switches with Company X2CDEROffice of Generic DrugsN/AN/A
52Quality by Design RoadmapCDEROffice of Generic DrugsN/AN/A
53Improving the Generic Drug Review Process and Review Queue ManagementCDEROffice of Generic DrugsN/AN/A
54Number of Commercial and Research INDs received in the monthCDEROffice of New DrugsN/AN/A
55Actions taken on marketing applications on time and past goal dates and the number of marketing applications receivedCDEROffice of New DrugsN/AN/A
56Actions taken on efficacy supplements on time and past goal dates and the number of marketing applications receivedCDEROffice of New DrugsN/AN/A
57Number of Postmarket Requirements (PMR) and Commitments (PMC) established and completed in the monthCDEROffice of New DrugsN/AN/A
5821st Century ReviewCDEROffice of New DrugsN/AN/A
59Professional Development TrainingCDEROffice of New DrugsN/AN/A
60Number of written Chemistry, Manufacturing, and Controls (CMC) reviews completed for INDs by ONDQA during the monthCDEROffice of New Drug Quality AssessmentN/AN/A
61Number of written Chemistry, Manufacturing, and Controls (CMC) reviews completed for NDAs by ONDQA during the monthCDEROffice of New Drug Quality AssessmentN/AN/A
62Number of written Chemistry, Manufacturing, and Controls (CMC) reviews completed for NDA supplements by ONDQA during the monthCDEROffice of New Drug Quality AssessmentN/AN/A
63The number of written Drug Master File reviews completed by ONDQA during the monthCDEROffice of New Drug Quality AssessmentN/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 AssessmentN/AN/A
65Number of ONDQA -managed product quality meetings held with sponsors in the monthCDEROffice of New Drug Quality AssessmentN/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 AssessmentN/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 AssessmentN/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 AssessmentN/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 AssessmentN/AN/A
70Implementation of Quality Management System (QMS) for CMC ReviewCDEROffice of New Drug Quality AssessmentN/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 EpidemiologyN/AN/A
72Number of manufacturer AE reports received in the month and the percentage received electronicallyCDEROffice of Surveillance and EpidemiologyN/AN/A
73Number of direct-to-FDA AE reports received in the month and the percentage received electronicallyCDEROffice of Surveillance and EpidemiologyN/AN/A
74Percent electronic-based expedited reports received in the month compared to paper-based expedited reportsCDEROffice of Surveillance and EpidemiologyN/AN/A
75Initial REMS reviews completed, REMS assessments completed, and REMS approved in the monthCDEROffice of Surveillance and EpidemiologyN/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 EpidemiologyN/AN/A
77Safety FirstCDEROffice of Surveillance and EpidemiologyN/AN/A
7818 Month, Ten Thousand Patient ReviewsCDEROffice of Surveillance and EpidemiologyN/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 BiostatisticsN/AN/A
80Number of submissions with electronic datasets reaching mid-cycle review during the monthCDEROffice of BiostatisticsN/AN/A
81Number of voluntary exploratory data submissions (VXDS) and biomarker qualification reviews completed per monthCDEROffice of Clinical PharmacologyN/AN/A
82Number of genomics Investigational New Drug (IND) and New Drug Application (NDA)/Biologics License Application (BLA) reviews completed per monthCDEROffice of Clinical PharmacologyN/AN/A
83Number of pharmacometrics IND and NDA/BLA reviews completed per monthCDEROffice of Clinical PharmacologyN/AN/A
84Number of pediatrics study reviews completed per monthCDEROffice of Clinical PharmacologyN/AN/A
85The number of cross-discipline reviews led by OCP as cross-disciplinary team leaders (CDTLs)CDEROffice of Clinical PharmacologyN/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 PharmacologyN/AN/A
87Total number of internal pediatric review committee meetings attended per monthCDEROffice of Clinical PharmacologyN/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 PharmacologyN/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 PharmacologyN/AN/A
90Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submitted and approved CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
91Number of New Molecular Entity (NME) NDAs and new BLAs submitted and approved CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
92Number of NDA and BLA efficacy supplements submitted CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
93Percentage of NDA related submissions in eCTD format and Total Number of NDA related submissions CDEROffice of Strategic ProgramsN/ARegulatory Review and Drug Safety
94Number of Fast Track designations, Accelerated Approval, Priority Reviews, and First Generics granted/approved CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
95Cumulative number of Presidential Emergency Plan for AIDS Relief (PEPFAR) drug approvals since 2004 CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
96Number of pediatric studies completed (under both PREA and BPCA) and deferred (under PREA) CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
97Number of biosimilar investigational new drug applications (INDs) received in the month CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
98Number of initial advisory meeting requests received and meetings held in the month CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
99Number 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
100Cumulative number of biosimilar development programs in the BPD Program in the month CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
101Number 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
102Number of Postmarketing Requirements (PMRs) and Commitments(PMCs) established and fullfilled/released CDEROffice of New DrugsN/ARegulatory Review and Drug Safety
103Number of 18 month, ten thousand patient reviews initiated CDEROffice of Surveillance and EpidemiologyN/ARegulatory Review and Drug Safety
104Number of Adverse Events (AE) reported for drugs/biological products CDEROffice of Surveillance and EpidemiologyN/ARegulatory Review and Drug Safety
105Number of Risk Evaluation Mitigation Strategy (REMS) reviews, assessments, and approvals CDEROffice of Surveillance and EpidemiologyN/ARegulatory Review and Drug Safety
106Number of pediatric safety reviews completed (BPCA, PREA, and Pediatric Rule) CDEROffice of Surveillance and EpidemiologyN/ARegulatory Review and Drug Safety
107Characterization of Biologically Derived Drug Products CDEROffice of Testing and ResearchN/ARegulatory Review and Drug Safety
108Percentage of complaints preliminarily reviewed and acknowledged within 30 days of receipt CDEROffice of Prescription Drug PromotionN/ADrug Quality and Compliance
109Number of recalls classified and products impacted by recall CDEROffice of ComplianceN/ADrug Quality and Compliance
110Percentage of recall classifications meeting the 26 calendar-day timeframe in the month CDEROffice of ComplianceN/ADrug Quality and Compliance
111Number of compounders that recalled products CDEROffice of ComplianceN/ADrug Quality and Compliance
112Number of warning letters issued to compounders and 503B outsourcing facilities CDEROffice of ComplianceN/ADrug Quality and Compliance
113Number of state referral letters issued concerning compounders CDEROffice of ComplianceN/ADrug Quality and Compliance
114Number of injuctions/consent decrees against compounders and 503B outsourcing facilities CDEROffice of ComplianceN/ADrug Quality and Compliance
115Cumulative number of registered outsourcing facilities CDEROffice of ComplianceN/ADrug Quality and Compliance
116Number of seizures or injunctions issued for unapproved drugs CDEROffice of ComplianceN/ADrug Quality and Compliance
117Number of actions to remove unapproved drugs from marketplace CDEROffice of ComplianceN/ADrug Quality and Compliance
118Number of warning letters issued for unapproved drugs that are not part of the class actions CDEROffice of ComplianceN/ADrug Quality and Compliance
119Number of seizures or injunctions issued for unapproved drugs CDEROffice of ComplianceN/ADrug Quality and Compliance
120Drug Supply Chain Security Act (DSCSA): National Standards for Prescription Drug Wholesale Distributors and Third-Party Logistics Providers CDEROffice of ComplianceN/ARegulatory Review and Drug Safety
121Number of external presentations to Societies, Consortia, Industrial and Government organizations CDEROffice of CommunicationsN/ATransparency and Public Outreach
122Number of Drug Safety Communications (DSCs) CDEROffice of CommunicationsN/ATransparency and Public Outreach
123Number of presentations, interactions with sponsors, and interagency working group meetings for drug development CDEROffice of Counter-Terrorism and Emergency CoordinationN/ATransparency and Public Outreach
124Rare Diseases Program CDEROffice of New DrugsN/ATransparency and Public Outreach
125Number of scientific and review publications published CDEROffice of Testing and ResearchN/ARegulatory Science and Research
126Number 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.