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Image Overlay - Is Regulatory Harmonization Between the FDA and the EMA Decreasing?
Image Overlay - Is Regulatory Harmonization Between the FDA and the EMA Decreasing?

Is Regulatory Harmonization Between the FDA and the EMA Decreasing?

September 11, 2019

Is Regulatory Harmonization Between the FDA and the EMA Decreasing?

Although the two agencies have historically agreed on over 90% of new drug approvals, a new study conducted by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) suggests that the EMA may be less likely to approve new drugs than the FDA. Regulatory harmonization is a critical concern for Yourway’s customers engaged in international clinical trials.

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