FDA发布PET药品NDA与ANDA申报内容与格式指南最终版，附件一为CMC格式示例
PET Drug Applications—Content and Format for NDAs and ANDAs
FDA发布PET药品NDA与ANDA申报内容与格式指南最终版，附件一提供化学、制造和控制部分的样品格式。该文件由FDA药品评价与研究中心（CDER）的PET指导委员会编写，日期为2011年8月，编号FDA-2000-D-1542。文件说明其代表FDA当前思考，不创设或授予任何权利，也不约束FDA或公众，可随时按21 CFR 10.115(g)(5)提交意见。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2000-D-1542
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Date: August 2011
These sample formats for the chemistry, manufacturing, and controls section have been prepared by the PET Steering Committee in the Center for Drug Evaluation and Research at the Food and Drug Administration. This document represents the Agency’s current thinking on the production of these positron emission tomography (PET) drug products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statues, regulations, or both.
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-2000-D-1542.
来源：FDA Pharmaceutical Quality Documents · fda.gov