FDA-TRACK: Center for Biologics Evaluation and Research Dashboard
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FDA's Center for Biologics Evaluation and Research (CBER) regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
Each FDA-TRACK program area collects, analyzes, and reports its performance measures and results. Explore the progress CBER is making towards it's strategic goals below:
I. Advancing Regulatory Science for Medical Counter Measures (MCM) Development Measures
A. Communicate Advances in MCM Regulatory Science
I. International Collaboration Measures
- Enhance collaboration with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection
- Engage in WHO pre-qualification of diagnostics pilot programme for HIV
- Collaborate in the development of a standardized Factor XIa reference reagent for Immune Globulin Thrombogenicity Testing
- Scientific collaboration and management of the Cooperative Agreement with WHO (World Health Organization) Year 4
I. Review Measures at the Center Level
A. Investigational New Drug Applications (IND) and Investigational Device Exemptions (IDE)
B. Marketing Applications: Biologics License Applications (BLA); New Drug Applications (NDA); Device Premarket Applications (PMA); and Premarket Notifications (510(k)s
C. BLA and NDA Efficacy Supplements; PMA Panel Track Supplements; Abbreviated New Drug Application (ANDA), Biosimilar Biological Project Application (BBPA) and NDA Supplements
D. BLA manufacturing supplements (all types)
E. Fast track designations granted, Accelerated Approval, and Priority Reviews
- Number of Fast track designations granted in the quarter
- Number of applications approved under Accelerated Approval in the quarter
- Number of Priority Reviews completed in the quarter
- Number of orphan drugs addressing rare diseases approved in the quarter
- Number of Breakthrough Therapy Designation Requests Received, Approvals, and Withdrawn After Granting (WAG) and Rescinded
F. Postmarket Requirements (PMR) and Postmarket Commitments (PMC)
G. Meetings (all types)
- Number of meetings held in the quarter and number of meetings cancelled by the requestor in the quarter because written feedback was provided prior to the scheduled meeting
- Number of meeting summaries issued in the quarter and the number of meeting summaries issued in the quarter that were past goal dates
II. Approval Letter Measure
A. Ensure completed CBER approval letters provided to Office of Communication Outreach and Development (OCOD) are reviewed for disclosure and posted on the web by a specified time period.
I. Product Recall Measures
A. Increase the percentage of blood and blood component recalls classified by the Office of Compliance and Biologics Quality (OCBQ) under the Direct Recall Classification program (DRC), within 45 days of receipt of additional information
- Increase the percentage of blood and blood component recalls classified by the Office of Compliance and Biologics Quality (OCBQ) under the Direct Recall Classification program (DRC), within 45 days of receipt of additional information
- Percentage of blood and blood component recalls classified by OCBQ under DRC, within 45 days of receipt of additional information
II. Use of Lot Distribution Data to Estimate Patient Exposure for Epidemiological Analysis of Adverse Event Reports Measure
A. Reported lot distribution data uploaded for use in the CBER regulatory database in the quarter
III. Review of Adverse Event Reports
A. Consistent and timely review of initial serious adverse event reports
Completed Measures and Key Project
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.