FDA Webinar on Updates on FDA’s Drug-Drug Interaction Final Guidances

FDA Webinar on Updates on FDA’s Drug-Drug Interaction Final Guidances

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) will host a free webinar on April 24, 2020 titled “Updates on FDA’s Drug-Drug Interaction Final Guidances.” Subject matter experts from CDER’s Office of Clinical Pharmacology will present highlights from two FDA final guidances: In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions and Clinical Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.

The simultaneous use of more than one medication is common, leading to an increased risk of drug-drug interactions (DDIs). Unanticipated, unrecognized, or mismanaged DDIs are a significant cause of morbidity and mortality associated with prescription drug use and have occasionally resulted in the removal of approved drugs from the market. Conversely, safe management of a DDI can allow approval of a drug that might otherwise have an unacceptable level of risk. Understanding clinically relevant DDIs between an investigational drug and other drugs is a critical component of drug development that informs the drug’s overall benefit/risk profile. The FDA’s two final guidances on DDIs are intended to assist drug developers in the planning and evaluation of DDI potential during drug development. The in vitro DDI guidance focuses on in vitro experimental approaches for evaluating metabolizing enzyme- and transporter-based drug interaction potential and how to extrapolate in vitro data to decide on the need for clinical DDI studies. The clinical DDI guidance focuses on clinical studies that evaluate DDIs that alter a drug’s pharmacokinetics by modulating the effects of drug metabolizing enzymes and/or transporters. It also advises sponsors on the timing and design of the clinical studies, interpretation of the results, and options for DDI management in patients. 

At the end of this webinar, participants should be able to:

• Understand the important role of in vitro DDI evaluations and how they inform clinical DDI assessment.
• Describe the need for, timing of, and multiple design features of clinical DDI studies.
• Interpret in vitro and clinical DDI study findings and translation of those findings into DDI management strategies that health care providers communicate to patients.

This webinar is free and is intended for scientists in pharmaceutical companies and contract research organizations working on drug metabolism, pharmacokinetics, and clinical pharmacology; regulatory reviewers and policy makers working in those areas; academic researchers in those fields; pharmacists; and healthcare providers prescribing drugs to patients.

Date:  Friday, April 24, 2020

Time:  1:30 pm to 3:00 pm (Eastern)

Additional details about this workshop, including registration, speakers, resources, and continuing education information are available at https://go.usa.gov/xvjEK.