Introduction Post marketing surveillance is defined as the process of gathering information about a particular product after its approval for public use. It comprises of case-control studies, adverse event monitoring, randomized trials, marketing surveys, analysis of important statistics and cohort studies. In the United States, drug manufacturers are required to provide evidence to FDA that the drugs they manufacture are efficient and safe. After the premarketing requirements are met, FDA has the capacity to withdraw the drugs from the market once it is discovered that the drug’s approval was made on the basis of unmet manufacturing conditions or false facts. In situations when a drug poses potential threat to the health of its users, its approval is suspended with an immediate effect followed by appropriate actions (Gill 121). Although it is not possible to provide information on the safety or efficacy of drugs when they are introduced to the market through postmarketing surveillance, various postmarketing surveillance kinds have been cited as crucial ways of monitoring and modifying the use of drugs. The main focus of proposals on postmarketing surveillance has been using prescription drugs safely, though the efficacy and safety considerations have been included as part of the focus. Currently, the interest in monitoring and prescription drug evaluation is on the process of premarketing approval and the duration taken before the drug is approved by FDA. Postmarketing surveillance supposedly has been losing its ground as a policy matter but it should be taken seriously as a policy matter for short-term and long-term aims (FDA 2). Events Pertaining to Post marketing Drug Surveillance Drug Approval Process During the approval process, sponsors of drugs must provide enough tests that confirm whether the drugs are safe for use under the prescribed or suggested conditions, and adequate evidence that the drug will deliver the effect it is supposed to deliver. This requirement led FDA into establishing a premarketing stage of drug testing that is comprised of two parts. The first process is the Investigational New drug (IND) application process while the second one is filing of a new drug application (NDA). IND application gives details on the qualifications of the investigator and the scheduled clinical tests, chemical composition of the drug and the new drug toxicology and pharmacology data (Strom and Velo 53). The clinical investigations during the IND process are sub-divided into three stages. The first stage is referred to as clinical pharmacology and involves testing the drug on human beings in order to confirm pharmacological effects and dose ranges. The number of subjects during this stage is dependent on the drug, but normally, it ranges between 20 and 80. The second stage is known as clinical investigation and comprises of clinical trials which are controlled to show the relative safety and efficiency of a drug. Clinical investigation procedures are done on a limited number of patients who are closely monitored. The number is usually between 200 and 300 patients with an equal number representing the control patients. The third stage is known