Drug Post-Launch Activities

Drug Post Launch Activities

Post-launch activities for a new drug require companies to rigorously track, report, and evaluate worldwide adverse event information. Such drug post-launch activities are critically important to ensure current benefit/risk profiles and the dissemination of labeling that fully describes the safe use of a drug product.

It is imperative that all sources of reported adverse events be closely monitored and fully evaluated and that any necessary follow-up studies are designed and conducted. Safety data should be derived from a variety of sources including the manufacturer’s internal studies, U.S. and foreign adverse event databases, spontaneous domestic and international adverse event reports and studies, ongoing U.S. and foreign trials, patient data repositories, the clinical and preclinical literature, international regulatory events, and other available databases.

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