FDA 发布《撒布用药品中微丸粒径》行业指南 Rev.1（FDA-2011-D-0021）

Size of Beads in Drug Products Labeled for Sprinkle

AI 导读

美国 FDA 药品评价与研究中心（CDER）发布行业指南《撒布用药品中微丸粒径》Rev.1，文件编号 FDA-2011-D-0021，2012 年 5 月定稿。该指南面向提交 NDA、ANDA 和 BLA 的申请人，说明对标注经撒布给药的药品（如含微丸的胶囊或小袋）中微丸适宜粒径范围的当前看法。公众可随时按 21 CFR 10.115(g)(5) 提交意见。

正文

GUIDANCE DOCUMENT

Size of Beads in Drug Products Labeled for Sprinkle Rev.1 Guidance for Industry May 2012

Final

Docket Number:

FDA-2011-D-0021

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance provides applicants preparing or submitting new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research’s current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).

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-2011-D-0021.