Definition: 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.
for general design, methodology, economics, etc. of phase IV clinical trials; a different heading CLINICAL TRIAL, PHASE IV is used for reports of a specific phase IV clinical trial
See AlsoDrug Toxicity
Other names Evaluation Studies, FDA Phase IV as Topic; Evaluation Studies, FDA Phase 4 as Topic; Drug Evaluation, FDA Phase IV as Topic; Drug Evaluation, FDA Phase 4 as Topic; Clinical Trials, Phase 4 as Topic
