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Guidance for Industry on Prussian Blue for Treatment of Internal Contamination With Thallium or Radioactive Cesium; Availability
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Zusammenfassung
The Food and Drug Administration (FDA) is announcing that we have concluded that prussian blue, when produced under conditions specified in approved new drug applications (NDAs), can be found to be safe and effective for the treatment of internal contamination with radioactive thallium, nonradioactive thallium, or radioactive cesium. We encourage the submission of NDAs for prussian blue drug products. We are also announcing the availability of a guidance for industry entitled "Prussian Blue Drug Products--Submitting a New Drug Application." This guidance is intended to assist manufacturers who plan to submit NDAs for prussian blue.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →