FDA发布药物共晶监管分类终版指南（FDA-2011-D-0800）
Regulatory Classification of Pharmaceutical Co-Crystals
FDA发布药物共晶固态形式监管分类的终版指南，文件编号FDA-2011-D-0800，由CDER发布。指南面向拟提交NDA和ANDA的申请人，说明共晶应如何监管分类，以及申请人应提交哪些数据支持该分类。文档同时说明该分类的监管影响，公众可随时就该指南提交意见。
该终版指南说明共晶固态形式在NDA与ANDA申请中的监管分类及所需支持数据，便于申请人定位分类依据。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2011-D-0800
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification.
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-0800.
来源：FDA Pharmaceutical Quality Documents · fda.gov