{"data":{"id":"us/21-cfr-601.32","jurisdiction":"us","citation":"21 CFR 601.32","heading":"General factors relevant to safety and effectiveness.","body":"FDA's determination of the safety and effectiveness of a diagnostic radiopharmaceutical includes consideration of the following:\n(a) The proposed use of the diagnostic radiopharmaceutical in the practice of medicine;\n(b) The pharmacological and toxicological activity of the diagnostic radiopharmaceutical (including any carrier or ligand component of the diagnostic radiopharmaceutical); and\n(c) The estimated absorbed radiation dose of the diagnostic radiopharmaceutical.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER F—BIOLOGICS","PART 601—LICENSING","Subpart D—Diagnostic Radiopharmaceuticals"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"3aaf823034aadc6308f3204fbb14b235c806559227b9dc36f8ff2fa3fa7956d3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-601.31","next":"us/21-cfr-601.33"},"notice":"GroundRules: Original legal text. Not legal advice."}