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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Center for Drug Evaluation and Research Dashboards

 

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FDA-TRACK: Drugs
FDA-TRACK Home
CDER Index

Policy and Science
Development

Pre-Approval Safety
Review

Post-Approval Safety
Monitoring

FDA’s Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. CDER also regulates other non-medicines that are considered to be drugs like fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens. CDER protects and advances public health by ensuring safe and effective drugs are available to improve the health of people in the United States.

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.

CDER promotes and protects public health in a variety of ways

FDA-TRACK: CDER - Policy and Science Development

Policy and Science Development

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. Explore the dashboard to learn more.

Pre-Approval Safety Review

Prior to approval, drugs go through many steps, or “phases” during the development and review process, some of which include clinical trials. Any drug approved by FDA must be demonstrated to be safe and effective. Both measures are extensively assessed during a drug’s premarket drug development process. Testing is conducted in a variety of progressive phases that begin with laboratory testing, move to animal testing, then to small groups of human subjects, and finally to larger groups of human subjects in full clinical trials. Since all drugs have risk, safety is assessed relative to the drug’s effectiveness. A drug’s benefits must outweigh its risks for the agency to consider it safe and effective. Explore these dashboards to learn more.

FDA-TRACK: CDER - Pre-Approval Safety Review
FDA-TRACK: CDER - Post-Approval Safety Monitoring

Post-Approval Safety Monitoring

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. Explore these dashboards to learn more.

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