Phase IV studies are additional studies performed after a regulatory approval of the drug and are sometimes referred to as "post-marketing" studies. The purpose of these studies is to gain broader understanding of the safety of the drug in the intended population or to secure approval for use in new indications
a surveillance study that further details the safety and effectiveness of a particular drug--usually the last phase of a treatment before it is approved by the Food and Drug Administration.
sometimes the FDA approves a drug for general use but requires to manufacturer to continue to monitor its effects; during phase IV the drug may be tried on slightly different patient populations than those studied in earlier trials
Large scale clinical trials carried out after regulatory approval designed to expand experience of the efficacy and safety of the drug, often in comparison with other treatments. Sometimes referred to as marketing support trials.
Phase IV trials are those undertaken after a drug has earned marketing approval, typically to gather additional information or pursue an additional indication.
Additional study of a drug or device that takes place after FDA approval.
post-approval clinical trials used to monitor safety and efficacy or examine additional applications of drugs.
At this phase, companies may also determine additional indications for the product/compound for which they could submit a supplemental NDA (sNDA).