Post-Marketing Surveillance

The goal of CDER's Post-Marketing Surveillance (PMS) system is to monitor the ongoing safety of marketed drugs. This is accomplished by reassessing drug risks based on new data learned after the drug is marketed, and recommending ways of trying to most appropriately manage that risk. This is done through a variety of activities and tools that are outlined below. This work is accomplished primarily through CDER's Division of Pharmacovigilance and Epidemiology.

	PMS Information Sources Chart- Provides an overview of the various drug experience and epidemiologic sources available to CDER in conducting surveillance and risk assessment of marketed drugs.
	MEDWatch- a description of FDA's medical product reporting program.
	Spontaneous Reporting System- For monitoring Adverse Drug Reaction Reports.
	Pharmacoepidemiology- Efforts of CDER's epidemiology staff in monitoring drug safety.
	Contracts/Cooperative Agreements- These provide important drug safety data on a national level.