CFR section
21 CFR 361.1(c)(3): 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(c)(3) |
|---|---|
| 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) | (3) Reports. Each Radioactive Drug Research Committee shall submit an annual report on or before January 31 of each year to the Food and Drug Administration, Center for Drug Evaluation and Research, HFD-160, 5600 Fishers Lane, Rockville, MD 20857. The annual report shall include the names and qualifications of the members of, and of any consultants used by, the Radioactive Drug Research Committee, and, for each study conducted during the preceding year, a summary of information presented in the… |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.