CFR section
21 CFR 361.1(d)(7): Radioactive drugs for certain research uses
PART 361-PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
Key facts
| Citation | 21 CFR 361.1(d)(7) |
|---|---|
| Section | Radioactive drugs for certain research uses |
| Part | PART 361-PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH |
| Subchapter | 21 CFR D Drugs Human |
| Product types cited | Drugs |
| Regulation text (excerpt) | (7) Research protocol. No matter how small the amount of radioactivity, no study involving administration of a radioactive drug, as defined in § 310.3(n) of this chapter, to research subjects under this section, shall be permitted unless the Radioactive Drug Research Committee concludes, in its judgment, that scientific knowledge and benefit is likely to result from that study. Therefore, the protocol shall be based upon a sound rationale derived from appropriate animal studies or published… |
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