Navigating Regulatory Scrutiny in Combined Clinical Trials

This research article analyzes the impact of the In Vitro Diagnostic Regulation (IVDR) on clinical trials in the EU, focusing on requests for information (RFIs) from regulatory bodies. It highlights common challenges faced by sponsors in dual submissions under IVDR and the Clinical Trial Regulation (CTR), offering actionable recommendations to enhance compliance and streamline processes. The authors provide insights based on real-world data to help regulatory professionals navigate the complexit