FDA 发布潮湿热终端灭菌人用与兽用药品参数放行申报资料最终指南
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
FDA 发布最终指南（Docket FDA-2008-D-0391），说明潮湿热终端灭菌的无菌产品在申报参数放行时需随申请资料提交哪些支持性信息。指南由兽药中心、生物制品评价与研究中心和药品评价与研究中心共同发布，适用于 NDA、ANDA、NADA、ANADA、BLA 及补充申请或其他上市后报告。文件为最终版，FDA 说明可随时就该指南在线或书面提交意见。
这份最终指南列出潮湿热终端灭菌无菌产品申报参数放行时需提交的支持性资料范围，并说明意见提交渠道。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2008-D-0391
- Issued by:
-
Guidance Issuing Office
Center for Veterinary Medicine
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This guidance provides recommendations to applicants on information to include in support of parametric release for sterile productsterminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other postmarketing report.
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-2008-D-0391.
来源：FDA Pharmaceutical Quality Documents · fda.gov