George O'Brien

George O'Brien

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In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more

8/1/2025  /  Administrative Procedure Act , Appeals , Chevron Deference , FDA Approval , Food and Drug Administration (FDA) , Loper Bright Enterprises v Raimondo , Orphan Drugs , Pharmaceutical Industry , Rulemaking Process , Statutory Interpretation
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