Overall Postmarketing Risk Assessment Is Complex Under the
current system, FDA shares responsibility for postmarketing risk
assessment with manufacturers, healthcare providers, user
facilities, and patients. Each participant has a role in
monitoring and evaluating adverse events associated with medical
products, as well as taking appropriate corrective action. The
roles assigned to manufacturers and the FDA are defined
primarily by statute, while the roles of other stakeholders are
more flexible in most cases. The specific objectives of FDA's
postmarketing risk assessment programs are to detect adverse
events not previously observed, improve understanding of the
potential severity of previously anticipated risks, detect
events resulting from drug interactions or drug effects in
particular populations, and assess the potential for causal
relationships. Manufacturers of prescription medical products
are required to submit adverse event reports to the FDA. In
addition, drug and biological product manufacturers m