To market a drug, the manufacturer must provide evidence of its efficacy and safety to the U.S. Food and Drug Administration (FDA) and specified Regulatory Authorities. In premarketing testing, the numbers and types of patients used to demonstrate a drug’s efficacy and safety are limited compared with the numbers and types of patients who will eventually be prescribed the drug after it is marketed. Although post-marketing surveillance cannot provide knowledge of the safety or efficacy of thugs at the time of their introduction on the market. Post-marketing surveillance of drug therefore play an important role to discover an undesirable effect that might present at risk. It provides additional information on the benefits and risk of the drugs.
This topic describes: Advantages, History, Sources of PMS information, Need Of Post-Marketing Surveillance, Methods of Post Marketing Surveillance, Controlled clinical trials, Spontaneous or voluntary reporting, Cohort studies, and Case-control studies.