Oral Drug Products Administered via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations." This draft guidance provides recommendations for consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube.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.