Regulatory innovation in postmarketing risk assessment and management.
The contemporary science of drug safety seeks not only to identify the risks associated with the use of medicines but also to quantify these risks, identify their risk factors, and assess strategies to minimize them. It monitors the use of medicines in actual practice to understand how the medical care system interacts with the intrinsic pharmacologic properties of medicines to produce the observed effects. To the extent possible, these analyses use a population-based approach that at times requires creativity and innovation. The key to effective safety management of drugs in the postmarketing setting is the ability to access sufficient good-quality data, interpret the data appropriately, challenge old assumptions, and define best practices in contemporary drug safety approaches.
Office of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, Maryland, USA. judy.staffa@fda.hhs.gov
J A
JA
Staffa
G J
GJ
Dal Pan
D016903:Drug Monitoring; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards; D018570:Risk Assessment; D012307:Risk Factors; D012308:Risk Management; D013223:Statistics as Topic; D019966:Substance-Related Disorders; D014481:United States; D014486:United States Food and Drug Administration