What is the FDA Drug Approval Process?

The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) reviews data from drug companies to ensure they are safe and effective before the company can sell them. The process involves a preclinical phase, clinical trials, New Drug Application (NDA) review, and post-marketing surveillance.

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FDA Drug Approval Process

A drug has a long journey from development to a store shelf. The FDA drug approval process is a rigorous evaluation that looks at everything from clinical study design to the risk of side effects of new drugs. The main purposes of the FDA drug approval process are

1. To ensure drugs, both brand-name and generic, are effective
2. Their health benefits outweigh their known risks (are safe)
3. Provide doctors and patients the information they need to use medicines wisely

The review team consists of physicians, statisticians, pharmacologists, and scientists. The CDER does not test drugs, but it does conduct drug quality, safety, and effectiveness research.