FDA 发布《已批准 NDA 或 ANDA 的变更；质量标准——对药典变更行使执法裁量权》最终指南（FDA-2004-D-0179）
Changes to an Approved NDA or ANDA; Specifications—Use of Enforcement Discretion for Compendial Changes
FDA 发布最终指南 FDA-2004-D-0179，就 21 CFR 314.70(c)(2)(iii) 行使执法裁量权：为符合官方药典而放宽接受标准或删除检验项目，若企业继续以年度报告提交，FDA 不打算采取执法行动。该条款原要求此类变更以 CBE-30 补充申请申报。FDA 表示将借此时机在后续修订《已批准 NDA 或 ANDA 的变更；问答》指南时明确部分变更可改为年度报告提交。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2004-D-0179
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance is intended to inform new drug application (NDA) and abbreviated new drug application (ANDA) holders of the Food and Drug Administration's (FDA’s) plan to use enforcement discretion with regard to section 314.70(c)(2)(iii) of the final rule entitled Supplements and Other Changes to an Approved Application (21 CFR 314.70(c)(2)(iii)). This subsection describes the filing requirement that a relaxation of acceptance criteria or deletion of a test to comply with an official compendium must be reported in a changes-being-effected-in-30- days supplement (CBE-30). In the exercise of its enforcement discretion, FDA does not intend to take enforcement action if manufacturers continue to submit such changes in their annual reports. The use of enforcement discretion will give the Agency time to clarify that some of these types of postapproval changes can be submitted in an annual report, rather than in a CBE-30. The Agency intends to clarify this issue in an upcoming revision to the guidance for industry Changes to an Approved NDA or ANDA; Questions and Answers.
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-2004-D-0179.
来源：FDA Pharmaceutical Quality Documents · fda.gov