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Lynn J. Howie, MD, MA

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Articles by Lynn J. Howie, MD, MA

A Comparison of FDA and EMA Drug Approval: Implications for Drug Development and Cost of Care

ByLynn J. Howie, MD, MA,Bradford R. Hirsch, MD, MBA,Amy P. Abernethy, MD, PhD
December 15th 2013

The development and approval of oncology therapeutics has been facilitated by the cooperation and coordination of regulatory practices between the EMA and the FDA. However, there continue to be important differences between the decisions of the two agencies.

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  • A Comparison of FDA and EMA Drug Approval: Implications for Drug Development and Cost of Care
    A Comparison of FDA and EMA Drug Approval: Implications for Drug Development and Cost of Care

    December 15th 2013



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