FDA发布经肠饲管给药口服制剂体外测试与标签建议草案

Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations

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FDA发布经肠饲管给药口服制剂体外测试与标签建议的行业指南草案，适用于除溶液外的多种口服剂型。草案涵盖颗粒、微丸、粉末、混悬液、胶囊和片剂等剂型，适用依据《联邦食品、药品和化妆品法案》505节及21 CFR 312和314部分提交的产品，Docket编号FDA-2021-D-0391。文件为Level 1草案，注明不供实施、不构成有约束力的建议，可随时提交意见。

推荐理由

草案列出经肠饲管给药口服制剂体外测试与标签建议的适用范围，并注明不具约束力、不供实施。

正文 · 原文

GUIDANCE DOCUMENT

Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Draft Guidance for Industry June 2021

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:

FDA-2021-D-0391

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

Center 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:

Submit Comments

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:

Dockets Management
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.