Postmarketing Surveillance
From DrugPedia: A Wikipedia for Drug discovery
Postmarketing Surveillance is a risk assessment program to identify adverse effects of drug after its approval.
FDA maintains a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug approval process. FDA monitors adverse events such as adverse reactions and poisonings. The Agency uses this information to update drug labeling, and, on rare occasions, to reevaluate the approval or marketing decision.
