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# AstraZeneca Comments on FDA QTc Draft Guidance
- URL: https://www.fdaweb.com/astrazeneca-comments-on-fda-qtc-draft-guidance/
- Published: 2023-10-05T12:00:00.000Z
- Updated: 2026-09-14T19:00:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155496

AstraZeneca has submitted both general and specific comments on an FDA draft guidance on QTc information in human prescription drug and biological product labeling. The company’s general comments were:

- the guidance does not define what the agency considers to be clinically relevant QTc interval prolongation;
- additional guidance is needed on study requirements for the “through QT/QTc study” cited in the guidance;
- guidance on how to update labeling materials when new QTc information becomes available should be considered; and
- the guidance does not emphasize the role of the integrated nonclinical and clinical risk assessment as presented in the International Council on Harmonization E14 and S7B guidances.