Regulatory Text
21 C.F.R. § 601.32 — General factors relevant to safety and effectiveness.
§ 601.32 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 radiopharmaceutical (including any carrier or ligand component of the diagnostic radiopharmaceutical); and (c) The estimated absorbed radiation dose of the diagnostic radiopharmaceutical.
Source: ecfr.gov · govinfo.gov — public domain
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Root-LD Entity Data
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Root-LD v1.0 · boisestandard.org
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BS-CFR21-SEC-164F16
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REGULATION / FEDERAL-CFR-SECTION
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boisestandard.org
Citation
21 C.F.R. § 601.32
Corpus
CFR — Code of Federal Regulations
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✓ ACTIVE
Source
PRIMARY-SOURCE
Source Verified
✓ TRUE
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1f90203abaea3639...
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Pending — corpus passes queued
The regulatory text of 21 C.F.R. § 601.32 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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Title 21 — Food and Drugs
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