US FDA · Final guidance
FDA publishes revised ICH E14/S7B questions and answers
Official source date: · Source checked
FDA lists final guidance clarifying clinical and nonclinical evaluation of QT/QTc prolongation and proarrhythmic potential. Revisions cover selected E14 questions and sections of S7B.
Who should review this?
Clinical development, nonclinical safety, cardiac-safety and regulatory affairs teams.
What it means for pharmaceutical teams
The Q&A supports interpretation of the ICH E14 and S7B guidances. Development teams should compare the revisions with their evidence plans rather than treat the announcement as a universal testing instruction.
Practical review checklist
PharmaEdges reading prompts for your own applicability review:
- Use the final R1 text when reviewing a relevant development programme.
- Check the revised E14 questions and S7B sections against your evidence.
- Document any applicable scientific or submission changes.
Official source and verification
Read the US FDA source (opens in a new tab)
This article summarises the linked official material. The context and checklist are PharmaEdges explanatory commentary, not additional regulatory requirements. The source publication date is separate from this article’s publication date.
For a correction, contact PharmaEdges with the article URL and supporting source. Read our news publishing policy.
Related fda intelligence
- FDA consults on essential drug-delivery performance characteristics
- FDA announces final guidance on prescription-drug companion software
- FDA finalises guidance on postapproval biosimilar manufacturing changes
- FDA publishes final ICH E2B(R3) guidance for electronic safety reports
- FDA proposes updated principles for container closure quality