Phase 4 Clinical Trials Definition

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Phase 4 Clinical Trials:

Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries.

Synonym: fda phase iv evaluation studies, fda phase iv drug evaluation, fda phase 4 evaluation studies, fda phase 4 drug evaluation, phase iv clinical trials.