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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Center for Drug Evaluation & Research

FDA-TRACK is FDA's agency-wide performance management program that monitors, analyzes and reports key performance data and projects for FDA's program offices and cross-cutting initiatives.

FDA’s Center for Drug Evaluation and Research (CDER) supports all aspects of drug development --- from the earliest stages of research and discovery, to approval by FDA and wide-spread use by the general public.  CDER works to ensure quality, safety, and effectiveness both before and after it approves any drug.  In other words, our efforts to protect public health extend throughout the entire life cycle of any drug we approve. Each quarter, using FDA-TRACK, CDER reports performance measures that highlight its involvement across this life cycle through policy and science development, pre-approval safety review, and post-approval safety monitoring.

For a complete list of CDER measures and their relevant FDA-TRACK dashboard, refer to the FDA-TRACK CDER Index.

CDER promotes and protects public health in a variety of ways

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Policy and Science Development
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Scientists from CDER work to establish and understand the complex elements of science needed to develop new drugs, especially those intended to treat unmet medical needs.

For additional information, click on the links below.

 

 

 

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Pre-Approval Safety Review
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Prior to approval, drugs go through many steps, or “phases” during the development and review process, some of which include clinical trials.

For additional information, click on the links below.

 

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Post-Approval Safety Monitoring
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FDA maintains a system of postmarket surveillance and risk assessment programs to identify and monitor adverse events that did not appear during the drug approval process. FDA also monitors issues that may occur with drug manufacturing, distribution, and availability.

For additional information, click on the links below.

 

 

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