THE US Food and Drug Administration (FDA) has released two draft guidance documents that aim to help drug developers evaluate investigational new drugs for potential drug-drug interactions.
The FDA says the guidances, which will replace 2012 draft guidance entitled "Drug Interaction Studies -- Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations," reflect the agency's efforts to help drug developers design drug-drug interaction studies that provide meaningful clinical information on how to manage risks when a patient is taking more than one medication.
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