Article | August 27, 2021

Regulatory Strategy Considerations For Working With The FDA vs. The EMA: Part 1

By Dominika Trzilova, PhD, Regulatory Scientist

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As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process. In this two-part blog series, we will explore the regulatory strategy considerations sponsors should bear in mind when working with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with a focus on the development of drug and biologic products.

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