Lynn Jackson Howie, Bradford R. Hirsch, Amy P. Abernethy
Abstract
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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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.
Key concepts: Drug development, Drug approval, Drug, Medicine, Approved drug, Pharmacology, Cancer drugs, Clinical research