Regulatory Hurdles in Clinical Trials: EU vs. US Regulatory Hurdles in Clinical Trials: EU vs. US
Table of Contents
Introduction
Regulatory Processes in the European Union
Harmonized Approach
Single Submission Portal
Parallel Assessment
Risk-Based Approach
Regulatory Processes in the United States
FDA Oversight
IND Application
Sequential Evaluation
Stringent Monitoring
Emphasizing the Ease of Conducting Trials in the EU...
