[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR315.3]

[Page 165-166]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 315--DIAGNOSTIC RADIOPHARMACEUTICALS--Table of Contents
 
Sec. 315.3  General factors relevant to safety and effectiveness.

    FDA's determination of the safety and effectiveness of a diagnostic 
radiopharmaceutical includes consideration of the following:
    (a) The proposed use of the diagnostic radiopharmaceutical in the 
practice of medicine,
    (b) The pharmacological and toxicological activity of the diagnostic

[[Page 166]]

radiopharmaceutical (including any carrier or ligand component of the 
diagnostic radiopharmaceutical), and
    (c) The estimated absorbed radiation dose of the diagnostic 
radiopharmaceutical.