FDA imaging agent draft guidance expands allowable indications to four broad categories.
This article was originally published in The Gray Sheet
FDA MEDICAL IMAGING DRUGS DRAFT GUIDELINE BROADENS INDICATIONS that can be claimed for imaging agents, 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 The four potential indications described in the draft guidance include structural localization; functional assessment or biochemical characterization; disease-specific indications; and management or decision-making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.
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