FDA发布E14与S7B QT/QTc间期延长及致心律失常潜力临床与非临床评价问答指南（R1）2026年10月版
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers (R1) Guidance for Industry October 2026
FDA发布ICH E14与S7B问答指南（R1）终版，文件编号FDA-2020-D-1791，用于澄清两项2005年10月指南的实施问题。修订版更新了E14第5.1、6.1和6.3问，并修订及新增S7B第1节和第3节问题。公众可随时按21 CFR 10.115(g)(5)提交意见。
GUIDANCE DOCUMENT
Final Level 2 Guidance
- Docket Number:
- FDA-2020-D-1791
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The question-and-answer (Q&A) document is intended to clarify key issues to facilitate implementation of the ICH guidances for industry E14 "Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs" (October 2005) and S7B "Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals" (October 2005). The revised Q&A document includes updates to Questions 5.1, 6.1, and 6.3 for E14, as well as revised and new questions for Sections 1 and 3 of S7B.
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-2020-D-1791.
来源：FDA 官方药品与生物制品信息 · fda.gov