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Trump’s FDA Nominee Eyes Rare Disease-Specific Review Pathways

Martin A. Makary, MD, nominated to be the next commissioner of the FDA, has stated that he will push to expedite reviews of new drugs for rare diseases. Makary, from Johns Hopkins University, pledged to customize the regulatory process to situations, suggesting, for example, that if a condition affects only a handful of people worldwide, two randomized control trials would not be necessary. His approach could benefit rare disease drug developers.

Source: www.genengnews.com –

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