Since the passing of the FDA Orphan Drug Act in1983, there has been an increasing focus on the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and treatment of rare diseases or conditions. As more pharmaceutical pipelines get filled with products under this classification, it is important to understand the underlying need and opportunities as well as the Food and Drug Administration (FDA) regulations in the orphan drug development landscape.

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