A Tale of Two Agencies: FDA and EMA Regulatory Guidance for NASH and the Impact On Program Design

 

Both the EMA and the FDA agree that identifying therapies to slow, halt, or reverse NASH/ NAFLD in patients represent a significant unmet need. Appropriate guidance has been structured to inform clinical programs across all key design elements, particularly for potentially pivotal trials. And although regulatory guidance may articulate similar strategic objectives, the detail required for program design and execution may deviate by phase of research. This whitepaper examines methods of reconciliation enabling one strategically focused clinical development program.