Despite court ruling, FDA will continue with its approach to approving orphan drug exclusivity

Stat News

23 January 2023 - In an unexpected move, the FDA will continue to apply exclusive marketing rights for so called orphan drugs under its existing regulations, rather than take a broader approach suggested by a federal court in a highly controversial case involving one such medicine.

Going forward, the agency will continue to confer seven years of marketing exclusivity for specific uses or indications for orphan drugs - the regulatory term for rare disease medicines - instead of allowing a drug company to win more expansive marketing rights, even of if the medicine is approved for some uses for treating a particular disease.

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Michael Wonder

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Michael Wonder

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Medicine , US , Orphan drug , Regulation