Global Approaches to Drug Development

When Ex-US clinical data can support US drug approvals

White Paper

May 22, 2019
GLOBAL APPROACHES TO DRUG DEVELOPMENT - WHEN EX-US CLINICAL DATA CAN SUPPORT US DRUG APPROVALS
As drug discovery and development capabilities continue to expand globally, pharmaceutical companies are increasingly interested in understanding the most efficient way to bring drugs to the US market based on a global clinical development strategy. This trend is not limited to established multi-national corporations, as an increasing number of emerging biopharmaceutical companies are seeking a global presence to better address unmet medical needs and to maximize their commercial opportunity.