FDA 发布《已批准 NDA 或 ANDA 的变更：问答》最终指南（FDA-1999-D-0049）
Changes to an Approved NDA or ANDA: Questions and Answers
FDA 药品评价与研究中心（CDER）发布《已批准 NDA 或 ANDA 的变更：问答》最终指南，编号 FDA-1999-D-0049，标注为 2001 年 1 月定稿。文件以问答形式回应申请人向 CDER 提出的问题，问答的标题与变更指南目录相对应。FDA 说明可就该指南随时提交意见，书面意见需标注该文件编号。
GUIDANCE DOCUMENT
Changes to an Approved NDA or ANDA: Questions and Answers Guidance for Industry January 2001
Final
- Docket Number:
- FDA-1999-D-0049
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This document provides questions and answers relating to the guidance on Changes to an Approved NDA or ANDA (the guidance).2 The questions are based on those posed to CDER by applicants. The questions and answers are presented using subject headings that correspond to the table of contents in the guidance
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-0049.
来源：FDA Pharmaceutical Quality Documents · fda.gov