FDA-TRACK: Center for Drug Evaluation & Research - Pre-Approval Safety Review
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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.
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.
For a complete list of CDER measures and their relevant FDA-TRACK dashboard, refer to the FDA-TRACK CDER Index.
FDA-TRACK CDER Home
Prior to approval, new drugs go through many steps, or “phases” during the approval process. They are first tested on animals, then on small groups of humans for preliminary safety information (phase 1) and again on small groups of people to get a preliminary review of the drug’s effectiveness (phase 2). Very few drugs make it past these early phases, as companies and/or CDER often find early signs that the drug may not be as safe or effective enough. For the relatively few drugs that pass these hurdles, phase 3 clinical trials are the next step. Generally, this phase involves a much larger group of people. Clinical trial patients take the drug over an extended period of time under the supervision of scientists and health care professionals who assess the overall risks and benefits of the drug. Drugs that still show potential for safety and effectiveness after phase 3 trials are the ones that FDA considers for approval. It is important to note that FDA is not responsible for conducting clinical trials. It assesses the data from clinical trials to evaluate drugs during the approval process.
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A biosimilar is highly similar to, and has no clinically meaningful differences in safety, purity, and potency (safety and effectiveness) from, an existing FDA-approved reference (originator) product. The goal of a biosimilar development program is to demonstrate biosimilarity between the proposed biosimilar product and the reference product, not to independently establish the safety and effectiveness of the proposed product.
The manufacturer of a proposed biosimilar product generates an array of data comparing the proposed product to the FDA-approved reference product to demonstrate biosimilarity. The comparative data are generated and evaluated in a stepwise fashion that begins with a foundation of detailed analytical (structural and functional) characterization and comparison of the products, moving on to animal studies if necessary and then to comparative clinical studies.
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Generic drugs are important options that allow greater access to health care for all Americans. Availability of generic drugs drives price competition and has helped millions of Americans obtain access to less costly but still safe and effective drug therapies. Generic drugs are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Through oversight of laboratory and other scientific testing and research that demonstrates “bioequivalence” between products, CDER works to ensure that generic drugs offer the same therapeutic value to patients as their brand name counterparts.
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