Patients frequently use more than one medication at a time. Unanticipated, unrecognized, or mismanaged DDIs are major causes of preventable morbidity and mortality, and have occasionally caused the withdrawal of approved drugs from the market. FDA’s goal is to effectively convey information about clinically important known and predicted DDIs in PDL to the HCP to help address this problem. Prescription drug labeling should include a summary of essential DDI information that is needed for the safe and effective use of the drug by the HCP. This information can include data and results from prospective clinical DDI studies (e.g., stand-alone DDI studies, nested DDI studies), population pharmacokinetic analyses, modeling and simulations, postmarketing reports, or data extrapolated from other information.
The objectives of this presentation will be to 1) Provide an overview of key labeling principles based upon regulation and information from recently published guidances, 2) Explore different labeling formats (e.g., tables, figures, structured text) to further enhance the presentation of DDI-related information in labeling; and 3) Discuss strategies for presenting DDI information based upon population analysis, modeling and simulation, or in vitro studies in PDL.