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Geschäft · 25.6.20131 Min. Lesezeit
Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality; Availability
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Zusammenfassung
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality." This guidance was initially published as a draft guidance on February 13, 2012. The draft was revised to clarify FDA's expectations and recommendations and to include references to a recently-developed assay for detecting ruminant contamination of crude heparin.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →