Applying real-world data to support regulatory decision — making in the United States

Abstract

The article describes the legal basis for the application of real-world data to support regulatory decision-making in the United States, as well as the possibility of implementing the relevant approaches in the legislation of the Eurasian Economic Union.

Keywords

• исследования реальной клинической практики
• пострегистрационное клиническое исследование
• неинтервенционное клиническое исследование