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Geschäft · 17.5.19991 Min. Lesezeit
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is issuing regulations on the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis and monitoring of diseases. FDA is issuing these regulations in accordance with the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). These regulations are intended to clarify existing regulations applicable to the approval of radiopharmaceutical drugs and biologics under the Federal Food, Drug, and Cosmetic Act (the act) and the Public Health Service Act (the PHS Act).
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →