Cardiovascular safety is a very important aspect in the development of many new medicines, and this issue is very important during the development of new oncological therapies. For this reason, the EMA has released a Concept Paper for public consultation regarding the need for a reflection paper on assessing cardiovascular safety in oncology medicinal products. While a 2016 Reflection Paper focused on cardiovascular safety in vascular and metabolic diseases, this new initiative aims to address oncology-specific considerations such as different medicines, patient populations, and trial designs. The proposed paper will offer guidance on planning, data collection, and evaluation of cardiovascular safety in oncology.
Public comments can be submitted by October 31, 2024.1
Access the paper here.
References
- European Medicines Agency. (2024). Concept paper on the need for a Reflection Paper on assessment of cardiovascular safety of oncology medicinal products. In European Medicines Agency. https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-reflection-paper-assessment-cardiovascular-safety-oncology-medicinal-products_en.pdf
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