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Dario Trapani: The potential implications on access of FDA vs EMA discrepancies

Dario Trapani/LinkedIn

Feb 10, 2025, 07:48

Dario Trapani: The potential implications on access of FDA vs EMA discrepancies

Dario Trapani, Medical Oncologist at the European Institute of Oncology, shared a post by Armando Genazzani, Full professor of Pharmacology at University of Turin, on LinkedIn, adding:

“In this latest policy analysis led by Martina Perini, Beatrice Castiglioni et al, we review the potential implications on access of FDA vs EMA discrepancies, identifying how a different set of normative practice may result in tangible differences!”

Quoting Armando Genazzani‘s post:

“Making decisions is hard, and making decisions when there is large uncertainty is ever harder. We recently compared labels of medicinal products which are marketed in the US and in Europe and found that about 50% of these include different patient populations. Differences are usually small but highlight the complexity of regulatory science.

Thanks to all the co-authors and all the regulators I have met along the way and that have shared with me the art of decision-making.”

Differences in the on-label cancer indications of medicinal products between Europe and the USA

Authors: Martina Perini et al.

Dario Trapani

Armando A. Genazzani Armando Genazzani Beatrice Castiglioni cancer Dario Trapani Elisabetta Galai EMA FDA Gianluca Miglio Martina Perini OncoDaily Oncology

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