CFR section

21 CFR 361.1(c)(2): 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)(2)
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) (2) Function. Each Radioactive Drug Research Committee shall select a chairman, who shall sign all applications, minutes, and reports of the committee. Each committee shall meet at least once each quarter in which research activity has been authorized or conducted. A quorum consisting of more than 50 percent of the membership must be present with appropriate representation of the required fields of specialization. Minutes shall be kept and shall include the numerical results of votes on…

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