FDA发布鼻喷雾剂与吸入溶液、混悬液及喷雾药品CMC资料最终指南
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation
FDA（CDER）发布鼻喷雾剂及吸入溶液、混悬液和喷雾药品的CMC资料最终指南，适用于NDA和ANDA申报。指南涵盖药品组分、生产工艺及相关控制，并提供标签建议。文件编号为FDA-1999-D-0060，不涉及原料药制造，也不涵盖推进剂型吸入与鼻用气雾剂、吸入粉末及鼻用粉末。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-1999-D-0060
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This document provides guidance for industry on the chemistry, manufacturing, and controls (CMC) documentation that should be submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nasal spray and inhalation solution, suspension, and spray drug products intended for local and/or systemic effect. This guidance covers CMC information recommended for inclusion in the application regarding the drug product components, manufacturing process, and associated controls for each of these areas, but does not address the manufacture of drug substances. The guidance also provides recommendations on labeling. This guidance does not address propellant-based inhalation and nasal aerosols (also known as oral and nasal metereddose inhalers, MDIs), inhalation powders (also known as dry powder inhalers, DPIs), and nasal powders.
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-1999-D-0060.
来源：FDA Pharmaceutical Quality Documents · fda.gov