400-9696-311 转1
400-9696-311 转2
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2020-09-29
FDA-2020-D-1791
指导原则
美国
现行有效
/
美国食品药品监督管理局(FDA)
GUIDANCE DOCUMENT
Not for implementation. Contains non-binding recommendations.
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential—Questions and Answers
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.
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