FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Medical Imaging Drugs Advisory Committee (MIDAC)
Upcoming Meetings
Past Meetings
Medical Imaging Drugs Advisory Committee (MIDAC)
MIDAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology and makes appropriate recommendations to the Commissioner of Food and Drugs.
The Committee discussed the potential risk of gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) procedures. A majority of the Committee agreed with the plans that were proposed by the FDA to address this potential risk, which included labeling and potentially requiring further additional safety studies.