Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Draft Guidance for Industry June 2021
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Devices and Radiological Health
This guidance provides recommendations regarding in vitro testing of oral drug products, other than solutions, administered via enteral feeding tube (hereinafter enteral tube). These products represent a wide range of oral dosage forms including, but not limited to, granules, pellets, powders, suspensions, capsules, and tablets. The recommendations for in vitro testing apply to products that are subject to the following and submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 21 CFR parts 312 and 314:
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-0391.