Works about 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.

Annotation

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

DUI

D017327 MeSH Browser

CUI

M0026314

Previous indexing

Clinical Trials (1980-1992)

History note

2008(1993)

Public note

2008; see CLINICAL TRIALS, PHASE IV 1993-2007; for DRUG EVALUATION, FDA PHASE IV see CLINICAL TRIALS 1981-1992; for EVALUATION STUDIES, FDA PHASE IV see CLINICAL TRIALS 1982-1992