Column
For much of the last twenty years, the direction of travel seemed clear. Regulators in US and EU have worked to harmonize requirements for market approval and thereby reduce unnecessary duplication of information. Companies have designed global development programs with the expectation that a single evidence package could support approvals in both US and EU.
Marie Gårdmark: Are FDA and EMA drifting apart?
Are FDA and EMA beginning to drift apart on what it takes to approve new medicines? And what could that mean for drug development on both sides of the Atlantic? Marie Gårdmark explores the question in a column.
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