The number of cannabidiol-based pharmaceutical products in the pipeline continues to grow, with the US Food and Drug Administration (FDA) recently granting yet another orphan drug designation for CBD.
The agency’s orphan drug programme is intended to encourage development of treatments for rare ailments affecting fewer than 200,000 people in the US (termed “orphan diseases”) or in other circumstances where it is unlikely that the cost of development will be recovered.
Created by the 1983 Orphan Drug Act, the designation does not permit products to be sold – an FDA marketing approval is still required for that – but it does allow manufacturers to benefit from tax breaks, reduced fees and other financial advantages, such as seven years’ protection from competition.
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