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For a variety of reasons the pharmaceutical industry over the last few years has become more and more interested in rare disease. This is great news for Rett Syndrome. As terms like orphan drug designation, breakthrough therapy, efficacy, drug approval, market exclusivity become part of our everyday lingo it is important that our understanding of them is based in facts. As we start the process of learning and sharing information we bring you this interview with regulatory consultant and Former Director of the FDA Office of Orphan Product Development, Timothy Coté.