A Tale of Two Agencies
FDA And EMA regulatory guidance for NASH and the impact on program design
While the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) agree in principle on the importance of identifying new therapies to reverse, halt, or slow the progress of NASH and NAFLD, each organization has articulated its guidelines for design and execution of such programs in unique ways. An understanding of the details of each agency’s guidance is crucial for those planning NASH and NAFLD clinical trials in both the US and Europe. Our whitepaper identifies the shared objectives of both agencies and parses the key points of divergence their respective guidances for clinical development in this important therapeutic area.