21 C.F.R. § 601.33 Indications.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 601—LICENSING
Subpart D—Diagnostic Radiopharmaceuticals
§ 601.33 Indications.
