On orphan drug exclusivity, FDA decides to go its own way after court loss
The FDA on Monday offered its latest perspective on how it will interpret the laws governing the seven years of orphan drug exclusivity granted to new rare disease drugs, following a controversial court loss that left many rare disease drugmakers in limbo.
The agency effectively decided to return to its old ways in making orphan exclusivity determinations, following the Office of Orphan Products Development’s decision to stop making these determinations since late 2021 due to the court loss.
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