Comparison of the EMA and FDA Guidelines on Ulcerative Colitis Drug Development

In 2016, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) released revised (EMA) or new (FDA) draft guidelines related to the development of drugs intended for the treatment of ulcerative colitis. We sought to compare and contrast the EMA draft guideline with the FDA draft guidance in order to facilitate further discussion and perhaps harmonization between the two guidelines when they are finalized.

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