FDA Releases Two Final Guidances on Drug Interactions Studies

Today the Food and Drug Administration (FDA) issued two final guidances for industry, “Clinical Drug Interaction Studies--Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions” and “In Vitro Drug Interaction Studies--Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.” The final guidances are intended to assist drug developers in evaluating drug-drug interaction (DDI) potential during drug development and describe a systematic, risk-based approach to the assessment of DDIs. In patients who take more than one medication, a DDI can cause unexpected side effects resulting in adverse events or death. Drug interaction studies can provide information to inform clinical risk management strategies for patients taking more than one medication. These guidances reflect the FDA’s current thinking in helping drug developers inform DDI management strategies.

For additional information on designing DDI studies or labeling, visit the Drug Development and Drug Interactions webpage.