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§ 315.4 - Indications.

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For diagnostic radiopharmaceuticals, the categories of proposed indications for use include, but are not limited to, the following:

Structure delineation;

Functional, physiological, or biochemical assessment;

Disease or pathology detection or assessment; and

Diagnostic or therapeutic patient management.

Where a diagnostic radiopharmaceutical is not intended to provide disease-specific information, the proposed indications for use may refer to a biochemical, physiological, anatomical, or pathological process or to more than one disease or condition.

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§ 315.3 - General factors relevant to safety and effectiveness.
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§ 315.5 - Evaluation of effectiveness.