Hi,

I do agree with the above issue in risk management.Risk assessment includes the estimation and evaluation of a risk. FDA’s premarketing risk assessment is intended to identify and quantify risks detected during clinical development and to evaluate how carefully any potential risks were assessed by the manufacturer. In addition, an evaluation of the risk of drug interactions as well as the potential for misadministration is performed. The known risks, along with any deficiencies in safety testing, are then weighed in the approval decision and described in the labeling of approved products.
FDA regulates the advertising and promotion of marketed products. Promotional materials must not be false, and they must not be misleading. In great part, this means that benefits should not be exaggerated and that risks should be presented clearly. Regulation of labeling, promotion, and advertising is intended to ensure that healthcare providers and consumers are adequately informed of the potential risks and benefits of the product, so that they can make decisions appropriate for each patient.
Irene Lloyd