The U.S. Food and Drug Administration (FDA) has issued a draft guidance titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” This guidance is aimed at assisting medical product sponsors in submitting “Diversity Action Plans” for certain clinical studies. These plans are designed to enhance the enrollment of historically […]

The European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation comes into force today, the 31st of January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. Prior to