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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 marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

Number of results: 115

	Item	Program	Office	Program Status	Type	Download
1	Total submissions routed to drug review	CDER	Office of Planning and Informatics	Completed	Program Measures
2	Percent of NDA related submissions in eCTD format in the month	CDER	Office of Planning and Informatics	Completed	Program Measures
3	Prescription Drug User Fee Act (PDUFA) Reauthorization	CDER	Office of Planning and Informatics	Completed	Key Projects
4	Percent of CDER positions staffed	CDER	Office of Management	Completed	Program Measures
5	Percent of CDER employees who reported 100% of their time during the quarter	CDER	Office of Management	Completed	Program Measures
6	Establish a CDER/NTEU Labor Management Council in Compliance with E.O. 13522	CDER	Office of Management	Completed	Key Projects
7	Create Project Roadmap for CDER/NTEU Labor Management Council	CDER	Office of Management	Completed	Key Projects
8	Percentage of 505(q) petition responses due in the month, completed by deadline	CDER	Office of Regulatory Policy	Completed	Program Measures
9	Employee Development	CDER	Office of Regulatory Policy	Completed	Key Projects
10	Number of drugs Advisory Committee meetings held that month	CDER	Office of Executive Programs	Completed	Program Measures
11	Number of Congressional correspondence requests received, GAO and IG assignments managed, and international inquiries received that month	CDER	Office of Executive Programs	Completed	Program Measures
12	Number of completed training activities that month	CDER	Office of Executive Programs	Completed	Program Measures
13	Equal Voice and Dispute Resolution	CDER	Office of Executive Programs	Completed	Key Projects
14	Total number of Public Inquiries by month (includes phone, email, and letter inquiries)	CDER	Office of Communications	Completed	Program Measures
15	Total number of training events in the month	CDER	N/A	Completed	Key Center Director Measures
16	Total number of CDER employees who completed the training events in the month	CDER	N/A	Completed	Key Center Director Measures
17	Number of IND submissions and amendments evaluated and reviews completed within the month	CDER	Office of Biotechnology Products	Completed	Program Measures
18	Number of NDA and BLA reviews completed and signed off within the month	CDER	Office of Biotechnology Products	Completed	Program Measures
19	Number of NDA and BLA supplement reviews completed and signed off within the month	CDER	Office of Biotechnology Products	Completed	Program Measures
20	Number of product manufacturing facilities site inspections and inspection related meetings which occurred during the month	CDER	Office of Biotechnology Products	Completed	Program Measures
21	Number of correspondences with applicants associated with INDs, BLAs, NDAs, sNDAs or sBLAs which occurred within the month	CDER	Office of Biotechnology Products	Completed	Program Measures
22	Number of industry meetings attended and number of OBP-managed product quality meetings held within the month	CDER	Office of Biotechnology Products	Completed	Program Measures
23	Number of external presentations to Societies, Consortia, Industrial and Government administered by OBP staff within the month	CDER	Office of Biotechnology Products	Completed	Program Measures
24	Number of Scientific and Review Publications published within the month	CDER	Office of Biotechnology Products	Completed	Program Measures
25	Implementation of Quality Management System (QMS) for Chemistry, Manufacturing, and Controls (CMC) Review	CDER	Office of Biotechnology Products	Completed	Key Projects
26	Percentage 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.	CDER	Office of Prescription Drug Promotion	Completed	Program Measures
27	Total 2253 pieces (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use) received	CDER	Office of Prescription Drug Promotion	Completed	Program Measures
28	Complaint letters received and reviewed regarding promotion materials in the month	CDER	Office of Prescription Drug Promotion	Completed	Program Measures
29	Direct to Consumer Monitoring	CDER	Office of Prescription Drug Promotion	Completed	Key Projects
30	Number of Warning Letter recommendations, Seizure actions, Disqualifications, and Injunction packages reviewed in the month	CDER	Office of Compliance	Completed	Program Measures
31	Number of class actions taken and Seizures or Injunctions issued in the quarter for unapproved drugs	CDER	Office of Compliance	Completed	Program Measures
32	Total number of recall events in the month for which the classification process was completed (includes recalls by Class and number of products impacted)	CDER	Office of Compliance	Completed	Program Measures
33	Number of new inquires received in the month	CDER	Office of Compliance	Completed	Program Measures
34	Number of Warning Letters issued in the quarter for unapproved drugs	CDER	Office of Compliance	Completed	Program Measures
35	Number of export certificate requests received and issued in the month	CDER	Office of Compliance	Completed	Program Measures
36	Number of presentations performed in the month	CDER	Office of Compliance	Completed	Program Measures
37	Compliance Program (CP) Updates	CDER	Office of Compliance	Completed	Key Projects
38	Compliance Program (CP) Updates - Implementation	CDER	Office of Compliance	Completed	Key Projects
39	Number of new research studies initiated within the month	CDER	Office of Testing and Research	Completed	Program Measures
40	Number of direct data communications, interim technical reports, and final technical reports with Review/Policy Divisions in the month	CDER	Office of Testing and Research	Completed	Program Measures
41	Assessment of histopathology practices in biomarker qualification	CDER	Office of Testing and Research	Completed	Key Projects
42	Marketplace Quality	CDER	Office of Testing and Research	Completed	Key Projects
43	Characterization of Biologically Derived Drug Products	CDER	Office of Testing and Research	Completed	Key Projects
44	Pediatric Platform Technologies	CDER	Office of Testing and Research	Completed	Key Projects
45	Rapid Screening of Pharmaceuticals	CDER	Office of Testing and Research	Completed	Key Projects
46	Quality Assessment of Repackaged Products	CDER	Office of Testing and Research	Completed	Key Projects
47	Number of New Bioequivalence Recommendations Posted in the month	CDER	Office of Generic Drugs	Completed	Program Measures
48	The number meetings with industry to provide guidance, presentations made to external organizations, and guidances initiated	CDER	Office of Generic Drugs	Completed	Program Measures
49	Number of applications received, applications pending, and actions taken	CDER	Office of Generic Drugs	Completed	Program Measures
50	Generic drug switch study with National Institutes of Health (NIH) / National Institute of Neurological Disorders and Stroke (NINDS) (epilepsy products)	CDER	Office of Generic Drugs	Completed	Key Projects
51	Study of anti-depressant generic drug switches with Company X2	CDER	Office of Generic Drugs	Completed	Key Projects
52	Quality by Design Roadmap	CDER	Office of Generic Drugs	Completed	Key Projects
53	Improving the Generic Drug Review Process and Review Queue Management	CDER	Office of Generic Drugs	Completed	Key Projects
54	Number of Commercial and Research INDs received in the month	CDER	Office of New Drugs	Completed	Program Measures
55	Actions taken on marketing applications on time and past goal dates and the number of marketing applications received	CDER	Office of New Drugs	Completed	Program Measures
56	Actions taken on efficacy supplements on time and past goal dates and the number of marketing applications received	CDER	Office of New Drugs	Completed	Program Measures
57	Number of Postmarket Requirements (PMR) and Commitments (PMC) established and completed in the month	CDER	Office of New Drugs	Completed	Program Measures
58	21st Century Review	CDER	Office of New Drugs	Completed	Key Projects
59	Professional Development Training	CDER	Office of New Drugs	Completed	Key Projects
60	Number of written Chemistry, Manufacturing, and Controls (CMC) reviews completed for INDs by ONDQA during the month	CDER	Office of New Drug Quality Assessment	Completed	Program Measures
61	Number of written Chemistry, Manufacturing, and Controls (CMC) reviews completed for NDAs by ONDQA during the month	CDER	Office of New Drug Quality Assessment	Completed	Program Measures
62	Number of written Chemistry, Manufacturing, and Controls (CMC) reviews completed for NDA supplements by ONDQA during the month	CDER	Office of New Drug Quality Assessment	Completed	Program Measures
63	The number of written Drug Master File reviews completed by ONDQA during the month	CDER	Office of New Drug Quality Assessment	Completed	Program Measures
64	Number of ONDQA correspondences with applicants associated with the CMC review of INDs, NDAs, or sNDAs occurred within the month	CDER	Office of New Drug Quality Assessment	Completed	Program Measures
65	Number of ONDQA -managed product quality meetings held with sponsors in the month	CDER	Office of New Drug Quality Assessment	Completed	Program Measures
66	Number of external presentations by ONDQA staff with professional societies, consortia, academia, or other government entity in the month	CDER	Office of New Drug Quality Assessment	Completed	Program Measures
67	Percentage of New Drug Applications (NDAs) for new molecular entities (NMEs) containing QbD elements. Cumulative total reported for the Fiscal Year.	CDER	Office of New Drug Quality Assessment	Completed	Program Measures
68	Percentage of New Drug Applications (NDAs) containing QbD elements (NME and non-NME). Cumulative total reported each Fiscal Year.	CDER	Office of New Drug Quality Assessment	Completed	Program Measures
69	Percentage of meetings with sponsors that include discussion of QbD information. Cumulative total reported for the Fiscal Year.	CDER	Office of New Drug Quality Assessment	Completed	Program Measures
70	Implementation of Quality Management System (QMS) for CMC Review	CDER	Office of New Drug Quality Assessment	Completed	Key Projects
71	Number of 18 month, ten thousand patient reviews inititated in the month(New Molecular Entities (NME) and non-NMEs)	CDER	Office of Surveillance and Epidemiology	Completed	Program Measures
72	Number of manufacturer AE reports received in the month and the percentage received electronically	CDER	Office of Surveillance and Epidemiology	Completed	Program Measures
73	Number of direct-to-FDA AE reports received in the month and the percentage received electronically	CDER	Office of Surveillance and Epidemiology	Completed	Program Measures
74	Percent electronic-based expedited reports received in the month compared to paper-based expedited reports	CDER	Office of Surveillance and Epidemiology	Completed	Program Measures
75	Initial REMS reviews completed, REMS assessments completed, and REMS approved in the month	CDER	Office of Surveillance and Epidemiology	Completed	Program Measures
76	Number of reviews completed under the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Research Equity Act (PREA), and the Pediatric Rule	CDER	Office of Surveillance and Epidemiology	Completed	Program Measures
77	Safety First	CDER	Office of Surveillance and Epidemiology	Completed	Key Projects
78	18 Month, Ten Thousand Patient Reviews	CDER	Office of Surveillance and Epidemiology	Completed	Key Projects
79	Number of Incoming NDAs, BLAs, and Efficacy Supplements with electronic datasets received and the percent received with data in SDTM and ADaM formats	CDER	Office of Biostatistics	Completed	Program Measures
80	Number of submissions with electronic datasets reaching mid-cycle review during the month	CDER	Office of Biostatistics	Completed	Program Measures
81	Number of voluntary exploratory data submissions (VXDS) and biomarker qualification reviews completed per month	CDER	Office of Clinical Pharmacology	Completed	Program Measures
82	Number of genomics Investigational New Drug (IND) and New Drug Application (NDA)/Biologics License Application (BLA) reviews completed per month	CDER	Office of Clinical Pharmacology	Completed	Program Measures
83	Number of pharmacometrics IND and NDA/BLA reviews completed per month	CDER	Office of Clinical Pharmacology	Completed	Program Measures
84	Number of pediatrics study reviews completed per month	CDER	Office of Clinical Pharmacology	Completed	Program Measures
85	The number of cross-discipline reviews led by OCP as cross-disciplinary team leaders (CDTLs)	CDER	Office of Clinical Pharmacology	Completed	Program Measures
86	Total 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 month	CDER	Office of Clinical Pharmacology	Completed	Program Measures
87	Total number of internal pediatric review committee meetings attended per month	CDER	Office of Clinical Pharmacology	Completed	Program Measures
88	Total 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 month	CDER	Office of Clinical Pharmacology	Completed	Program Measures
89	Total number of new labels (postmarketing) approved in the month that include clinical pharmacology review on pharmacogenetic, drug-drug interactions and specific population information, etc.	CDER	Office of Clinical Pharmacology	Completed	Program Measures
90	Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submitted and approved	CDER	N/A	Active	Program Measures
91	Number of New Molecular Entity (NME) NDAs and new BLAs submitted and approved	CDER	N/A	Active	Program Measures
92	Number of NDA and BLA efficacy supplements submitted	CDER	N/A	Active	Program Measures
93	Percentage of NDA related submissions in eCTD format and Total Number of NDA related submissions	CDER	N/A	Active	Program Measures
94	Number of Fast Track designations granted, Accelerated Approval, Priority Reviews, and First Generics	CDER	N/A	Active	Program Measures
95	Cumulative number of Presidential Emergency Plan for AIDS Relief (PEPFAR) drug approvals and tentative approvals since 2004	CDER	N/A	Active	Program Measures
96	Number of pediatric studies completed (under both PREA and BPCA)	CDER	N/A	Active	Program Measures
97	Number of core initial promotional campaign material reviews completed in the month and percentage completed within timeframe	CDER	N/A	Active	Program Measures
98	Number of Postmarketing Requirements (PMRs) and Commitments(PMCs) established and fullfilled/released	CDER	N/A	Active	Program Measures
99	Number of 18 month, ten thousand patient reviews initiated	CDER	N/A	Active	Program Measures
100	Number of Adverse Events (AE) reported for drugs/biological products	CDER	N/A	Active	Program Measures
101	Number of Risk Evaluation Mitigation Strategy (REMS) reviews, assessments, and approvals	CDER	N/A	Active	Program Measures
102	Number of pediatric safety reviews completed (BPCA, PREA, and Pediatric Rule)	CDER	N/A	Active	Program Measures
103	Characterization of Biologically Derived Drug Products	CDER	N/A	Active	Key Projects
104	Number and Percentage of complaints preliminarily reviewed and acknowledged within 30 days of receipt	CDER	N/A	Active	Program Measures
105	Number of recalls classified and products impacted by recall	CDER	N/A	Active	Program Measures
106	Percentage of recall classifications meeting 26 calendar-day timeframe in the month	CDER	N/A	Active	Program Measures
107	Number of actions to remove unapproved drugs from marketplace	CDER	N/A	Active	Program Measures
108	Number of Warning Letters issued for unapproved drugs that are not part of the class actions	CDER	N/A	Active	Program Measures
109	Number of seizures or injunctions issued for unapproved drugs	CDER	N/A	Active	Program Measures
110	Number of external presentations to Societies, Consortia, Industrial and Government organizations	CDER	N/A	Active	Program Measures
111	Number of DSC (Drug Safety Communications)	CDER	N/A	Active	Program Measures
112	Number of presentations, interactions with sponsors, and interagency working group meetings for drug development	CDER	N/A	Active	Program Measures
113	Rare Diseases Program	CDER	N/A	Active	Key Projects
114	Number of Scientific and Review Publications published	CDER	N/A	Active	Program Measures
115	Number of guidances issued	CDER	N/A	Active	Program Measures