Orphan Insights, Part 1: Orphan Drug Designations

Orphan Insights is a series of Q&A assembled from the many discussions I have with companies developing medicines and therapies for rare diseases who are seeking regulatory advice. These questions are related to when, why and how to engage with the regulators, and take advantage of the various designations applicable to their orphan program. Each “Part” in this series will pose 3-4 questions and offer strategic and thought-provoking responses.

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