FDA发布吸入气雾剂（MDI）和吸入粉雾剂（DPI）药品质量考量草案指南并征求意见

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality Considerations

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FDA发布吸入气雾剂（MDI）和吸入粉雾剂（DPI）药品质量考量草案指南，文件标注不用于实施，仅含非约束性建议。指南就这两类产品的开发和生产向行业提出建议，适用于拟用于局部或全身作用的MDI和DPI产品。意见可随时通过在线或书面方式提交，书面意见须标注案卷编号FDA-2018-D-1098。

推荐理由

FDA发布的草案指南就吸入气雾剂与吸入粉雾剂的开发和生产向行业提出建议，并列出可随时提交意见的渠道。

正文 · 原文

GUIDANCE DOCUMENT

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:

FDA-2018-D-1098

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers (or MDIs)) and inhalation powders (also known as dry powder inhalers (or DPIs)). The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.

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-2018-D-1098.