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Abstract:
Consumers expect regulatory authorities to evaluate the risks and benefits of non-narcotic analgesics both before marketing and throughout their marketing life. In making their evaluation, regulatory authorities attempt to ensure that before a product is marketed it is of satisfactory quality, is efficacious, tested for likely toxicological hazards and that prescribers are provided with appropriate, objective information. After marketing of a drug, regulatory authorities use spontaneous adverse drug reaction (ADR) reporting systems as their principal monitoring technique and use the data collected to help identify risk factors for human toxicity.