FDA 发布刻痕片评分命名、标签与评估数据最终指南（FDA-2011-D-0595）
Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
FDA 发布最终指南，就刻痕片评分的命名、标签与评估数据向 NDA 和 ANDA 申报者提出建议。文件编号为 FDA-2011-D-0595，由 CDER 下设指南发布办公室签发。指南指出刻痕特征便于片剂分劈，并说明可依据 21 CFR 10.115(g)(5) 随时提交意见。
文件面向 NDA 与 ANDA 申报者，说明刻痕片在评估与标签方面应满足的标准，便于定位申报时需核对的评分依据。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2011-D-0595
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored. (A scoring feature facilitates the practice of tablet splitting. )
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-0595.
来源：FDA Pharmaceutical Quality Documents · fda.gov