Need for a reflection paper on assessment of cardiovascular safety of oncology medicinal products - Scientific guideline

The purpose of the reflection paper considered in the concept paper is to provide recommendations for the planning, collection of data and evaluation of cardiovascular safety of oncology medicinal products taking into account specific issues that apply to the oncology setting with respect to type of medicinal products applied, patients and trials designs.

Keywords: Cardiovascular safety, oncology, anti-cancer drugs

Current version

Concept paper on the need for a reflection paper on assessment of cardiovascular safety of oncology medicinal products

Consultation dates: 01/08/2024 to 31/10/2024Draft: consultation openReference Number: EMA/CHMP/322756/2024Summary:

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