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# FDA QTc Draft Guidance ‘Too Vague’: NCHR
- URL: https://www.fdaweb.com/fda-qtc-draft-guidance-too-vague-nchr/
- Published: 2023-10-10T12:00:00.000Z
- Updated: 2026-09-14T19:01:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155524

The National Center for Health Research (NCHR) says that while an FDA guidance is needed to help sponsors develop labeling that includes clinically relevant information about the QTc interval, the guidance the agency has drafted “is too vague to be clinically useful or to meaningfully improve patient care.” In its comment [letter](https://downloads.regulations.gov/FDA-2023-D-2439-0006/attachment%5F1.pdf?ref=fdaweb.com), NCHR says:

- FDA should provide more information about the conducting of thorough QT studies as the proposed guidance will allow for inconsistency and limited interpretability among healthcare professionals;
- FDA should require sponsors to include information on the label and in the package inserts about which of the QTc formulas they used in the development of their product;
- the guidance should recommend that sponsors examine drug-drug interactions and drug-disease interactions on the physiologic QT interval or corrected QT interval; and
- FDA should ensure that QTc labeling, package inserts, and medication guides are prepared for patients in clear, plain language to better inform them of their medication’s risks and adverse effects.