§ 315.4 - Indications.

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Related Notices
- 99-12320. Final rule. 99-12320. Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
- 98-13797. Proposed rule. 98-13797. Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

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§ 315.4 Indications.

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

(1) Structure delineation;

(2) Functional, physiological, or biochemical assessment;

(3) Disease or pathology detection or assessment; and

(4) Diagnostic or therapeutic patient management.

(b) 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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§ 315.4 - Indications.

§ 315.4 Indications.