FDA 发布 ANDA 申报良好实践定稿指南
Good ANDA Submission Practices
FDA 发布 Good ANDA Submission Practices 定稿指南，用于帮助申请人准备简略新药申请（ANDA）。指南归纳了可能导致 ANDA 审批延迟的常见反复缺陷，并提出避免这些缺陷、减少审评轮次的建议。该文件为定稿的一级指南，档案编号 FDA-2017-D-6854，公众可随时按 21 CFR 10.115(g)(5) 提交意见。
FDA 发布的定稿指南归纳了可能导致 ANDA 审批延迟的常见缺陷，并建议申请人如何避免以减少审评轮次。
GUIDANCE DOCUMENT
Final Level 1 Guidance
- Docket Number:
- FDA-2017-D-6854
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for approval.
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-2017-D-6854.
来源：FDA Pharmaceutical Quality Documents · fda.gov