What the FDA Looks for in Global Development Programs Today
Multi-regional clinical trials (MRCTs) play a critical role in global drug development, but regulatory expectations for these studies continue to evolve. Sponsors must now demonstrate not only robust global data, but also clear scientific rationale for regional enrollment strategies and consistency of treatment effects across populations.
This forthcoming white paper by Dr. Harpreet Singh, Chie Medical Officer and former FDA Director, Division of Oncology 2, explores how FDA evaluates MRCT data today — and why some global programs succeed while others encounter regulatory hurdles.
What the Whitepaper Will Examine
- How FDA thinking on MRCT applicability has evolved
- Why global efficacy does not always translate into U.S. approval
- What regulators consider when assessing regional representation and consistency
- How sponsors can approach MRCT design with regulatory expectations in mind
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