The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations.” This draft guidance provides recommendations for consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral feeding tube.
The recommendations for in vitro testing apply to the following products:
- New drug applications (original or supplemental) where applicants are seeking and/or revising enteral feeding tube administration instructions and related information in labeling
- Abbreviated new drug applications where the reference listed drug (RLD) contains enteral feeding tube administration instructions and related information in labeling
- Investigational new drug applications where the investigational drug product is administered or planned for administration via enteral feeding tube
This guidance discusses in vitro testing recommendations to ensure oral drug product quality and, as applicable, bioequivalence to the reference listed drug when evaluating a drug product’s suitability for administration via enteral feeding tube. It also provides the appropriate content and format for submission of in vitro testing results regarding administration via enteral feeding tube, as well as recommendations on how to incorporate information about administration via enteral feeding tube in drug product labeling when supported by in vitro testing results.
Providing recommendations for in vitro testing of oral drug products administered via enteral feeding tube will support the development of clear, product-specific enteral feeding tube administration instructions in labeling for administration to patients unable to ingest oral drug products. The goal is to establish applicable in vitro methodology and provide information in drug product labeling for safe and effective administration of oral drug products through enteral feeding tubes
