Diese Übersetzung wird noch vorbereitet. Bis dahin zeigen wir vorübergehend die englische Originalversion.
Geschäft · 3.6.20211 Min. Lesezeit
Oral Drug Products Administered via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations; Draft Guidance for Industry; Availability
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations." This draft guidance provides recommendations for consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube. In addition, it supports the development of clear product-specific enteral tube administration instructions in labeling for administration to patients unable to ingest oral drug products.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →