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Imprese · 17/05/19991 min di lettura

Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

Traduzione automatica locale · Lingua originale della fonte

Riepilogo

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).

Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →

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