FDA medical imaging agent draft guidance expands allowable indications to four categories.
Executive Summary
FDA MEDICAL IMAGING DRUGS DRAFT GUIDELINE EXPANDS AGENT INDICATIONS, incorporating suggestions made by the Council on Radionuclides and Radiopharmaceuticals in January. The four potential indications described in the draft guidance include structural localization; functional assessment or biochemical characterization; disease-specific indications; and management or decision-making indications. The Medical Imaging Drugs Advisory Committee met to discuss the draft on July 23, the third meeting of a series on developing the guidance document.