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2010-09-23
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International Conference on Harmonisation; Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; Availability
Notices
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United States
Department of Health and Human Services
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Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non- Antiarrhythmic Drugs.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations to sponsors concerning clinical studies to assess the potential of a new drug to cause cardiac arrhythmias, focusing on the assessment of changes in the QT/QTc interval on the electrocardiogram as a predictor of risk. The guidance is intended to encourage the assessment of drug effects on the QT/QTc interval as a standard part of drug development and to encourage the early discussion of this assessment with FDA.
70 FR 61134
https://www.govinfo.gov/app/details/FR-2005-10-20/05-20971
05-20971
fr20oc05-54
4160-01-S
Docket No. 2004D-0377
https://www.govinfo.gov/app/details/FR-2005-10-20/05-20971
https://www.govinfo.gov/content/pkg/FR-2005-10-20/html/05-20971.htm
https://www.govinfo.gov/content/pkg/FR-2005-10-20/pdf/05-20971.pdf
2 p.
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70 FR 61134
International Conference on Harmonisation; Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; Availability; Federal Register Vol. 70, Issue
NOTICE
05-20971
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2004D-0377
4160-01-S
05-20971
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non- Antiarrhythmic Drugs.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations to sponsors concerning clinical studies to assess the potential of a new drug to cause cardiac arrhythmias, focusing on the assessment of changes in the QT/QTc interval on the electrocardiogram as a predictor of risk. The guidance is intended to encourage the assessment of drug effects on the QT/QTc interval as a standard part of drug development and to encourage the early discussion of this assessment with FDA.
Submit written or electronic comments on agency guidances at any time.
Regarding the guidance: Douglas C. Throckmorton, Center for Drug Evaluation and Research (HFD-1), Food and Drug Administration, 5600 Fishers Lane, Rockville MD, 20857, 301-594-5400.
Reports and guidance documents; availability, etc.:
International Conference on Harmonization
QT/QTc interval prolongation and Proarrhythmic potential for non-antiarrhythmic drugs; E14 clinical evaluation,
http://www.fda.gov/cber/publications.htm
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
Federal Register
Vol. 70, no. 202
Office of the Federal Register, National Archives and Records Administration
2005-10-20
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196 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2005-10-20
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https://www.govinfo.gov/app/details/FR-2005-10-20
https://www.govinfo.gov/content/pkg/FR-2005-10-20/pdf/FR-2005-10-20.pdf
https://www.govinfo.gov/content/pkg/FR-2005-10-20/xml/FR-2005-10-20.xml
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2010-09-23
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