FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Medical Imaging Drugs Advisory Committee (MIDAC)

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Medical Imaging Drugs Advisory Committee

On Tuesday, March 5, 2024, the Medical Imaging Drugs Advisory Committee will discuss efficacy and safety data submitted by submitted by Lumicell in support of a new drug application (NDA) 214511 for pegulicianine for injection. The proposed indication for pegulicianine is for use in patients with breast cancer to assist in the detection of cancerous tissue within the lumpectomy cavity following removal of the primary specimen during lumpectomy surgery.

Medical Imaging Drugs Advisory Committee

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.

Medical Imaging Drugs Advisory Committee

The Committee supported, by a vote of 11-Yes to 0-No, with no abstentions, the safety and efficacy of 5-aminolevulinic acid (5-ALA), powder for oral solution, by NX Development Corp. (NXDC) for use as an imaging agent during glioma surgery.

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.

FDA Committee Website