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good afternoon my name is anthony fotinos and im a clinical team leader in the division of imaging and radiation medicine and fdas office of new drugs in the last session donna roskow spoke about oncology therapy in which patient selection hinges on whether the output of a companion device is interpreted as positive or negative what if therapeutic decision making hinges instead on pre-therapy administration of a pharmaceutical drug or biologic what if compared to information sourced from in vitro samples removed from the patient part of the administered active ingredient disintegrates and emits nuclear particles or photons directly from sources of biodistribution within the patient in this case were talking about radiopharmaceuticals the subject my colleague donna kopfluku and i will be discussing together over the next half hour i will provide an overview of radio pharmaceutical regulation from a clinical perspective and donaco will go more in depth on scientific aspects unique to