This system, when functioning well, succeeds in managing a balance between benefit and risk. FDA also operates postmarketing surveillance programs intended to identify unexpected risks of approved products. When new risks are identified in a medical product, the manufacturer adds them to the labeling, or, if serious enough, they may trigger an Agency reevaluation of the approval decision. For products of acceptable quality, the central element of FD A s risk management is controlling product entry to the marketplace. The majority of FDA program resources are devoted to premarketing scientific risk identification and assessment and approval or nonapproval.
Trials expose only a relatively small number of people to a product.
The number of patients exposed to a product increases 1,000-fold or more when the new product moves from the clinical trial setting to the real world setting. 2.Clinical trial patients aren't real world patients. To achieve homogeneity, clinical trials often systematically exclude special populations C patients with concurrent diseases, with concurrent drug use, or at age extremes, or who otherwise are felt to be at risk of noncompliance. Trials also often exclude people with any other factors that may make it more difficult to measure effectiveness. Yet, the people being excluded may be precisely the people who ultimately will be using a product and in whom toxicities are most likely to occur.