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Phases
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Clinical Trial, Phase II. In this phase, controlled studies of approximately 100 to 300 volunteer patients (people with the disease) assess the drug's effectiveness. These studies are about 2 years. Clinical Trial, Phase III. This phase lasts about three and one half years and usually involves 1,000 to 3,000 patients in clinics and hospitals. Physicians monitor patients closely to determine efficacy and to identify adverse reactions. New Drug Application (NDA). Following the completion of all three phases of clinical trials, the company analyzes all of the data and files the NDA with the FDA if the data successfully demonstrate safety and effectiveness. By law, the FDA is allowed six months to review the NDA. The average review time for new drug compounds approved in 1996 was 17.8 months. Approval. Once FDA approves the NDA, the new medicine becomes available for physicians to prescribe. The FDA requires additional (these 4) studies to evaluate long-term effects.
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